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Genetic Analysis in Identifying Late-Occurring Complications in Childhood Cancer Survivors

This study is currently recruiting participants.
Verified August 2017 by Children's Oncology Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT00082745
First Posted: May 19, 2004
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose
This clinical trial studies cancer survivors to identify those who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

Condition Intervention
Cancer Survivor Cardiovascular Complication Malignant Childhood Neoplasm Other: Laboratory Biomarker Analysis Other: Questionnaire Administration

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Key Adverse Events After Childhood Cancer

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Rate of adverse events (cardiac dysfunction, AVN, ischemic stroke, and SMN using a matched case-control) [ Time Frame: Up to 1 year ]
    Epidemiological, clinical and laboratory variables will be tested for their association with key adverse events. McNemar's test for paired data will be used to compare the unmatched general characteristics of cases and controls.

  • Frequency of mutations or polymorphisms in specific candidate genes in cases and controls [ Time Frame: Up to 1 year ]
    Allele frequencies will be estimated by the gene counting method, and the chi-square test will be used to check for departures from Hardy-Weinberg equilibrium.

  • Crude disease-exposure [ Time Frame: Up to 1 year ]
    The crude disease-exposure association will be determined by estimating the OR and its 95% confidence interval (CI). This will be done by univariate conditional logistic regression, to account for the matched design. The significance of the OR will be assessed by the Wald test. Backward stepwise regression procedures will be used to develop the final multivariate model and possible interactions will be examined. The fit of the model will be assessed by the logistic regression diagnostics procedure.


Biospecimen Retention:   Samples With DNA
peripheral blood or buccal sample

Estimated Enrollment: 8100
Study Start Date: March 2004
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (genetic analysis)
DNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To identify key adverse events developing in patients (cases) with a primary cancer diagnosed at age 21 or younger.

II. To characterize the key adverse events with respect to the nature of the primary malignancy (pathology, stage) and coded details of the therapeutic protocol.

III. To identify treatment-related and demographic risk factors through a direct comparison of the case-group and controls identified from the remaining patients with the same primary diagnosis.

IV. To compare the frequency of mutations or polymorphisms in specific candidate genes in cases and controls, using constitutional deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) from the cases and controls.

V. To explore the role and nature of gene-environment interaction in the development of key adverse events.

OUTLINE:

DNA and RNA from peripheral blood or buccal sample of patients is analyzed for the presence of polymorphisms in candidate genes associated with an increased risk of late-occurring complications.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of primary cancer at age 21 or younger meeting other criteria
Criteria

Inclusion Criteria:

  • ELIGIBILITY CRITERIA - CASES
  • Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  • Development of one of the following key adverse events at any time following initiation of cancer therapy:

    • Cardiac dysfunction; please note: case enrollment has been closed due to achievement of target accrual
    • Ischemic stroke (IS)
    • Subsequent malignant neoplasm (SMN)
    • Avascular necrosis (AVN); please note: case enrollment has been closed due to achievement of target accrual
  • Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements; please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's white blood cell (WBC) is > 2,000
  • Written informed consent from the patient and/or the patient's legally authorized guardian
  • In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
  • ELIGIBILITY CRITERIA - CONTROLS
  • CONTROL: Diagnosis of primary cancer at age 21 or younger, irrespective of current age
  • CONTROLS: No prior history of allogeneic (non-autologous) hematopoietic cell transplant
  • CONTROLS: No clinical evidence of any of the following key adverse events:

    • Cardiac dysfunction (CD); please note: if a patient is currently receiving active cancer treatment, it is preferable to obtain the blood sample at a time when the patient's WBC is > 2,000
    • Myocardial infarction (MI)
    • Ischemic stroke (IS)
    • Avascular necrosis (AVN)
    • Subsequent malignant neoplasm (SMN)
  • CONTROLS: Submission of a blood specimen (or in certain cases a buccal cell specimen) to the Clinical Pharmacokinetics Laboratory at St. Jude Children's Research Hospital as per the requirements
  • CONTROLS: Written informed consent from the patient and/or the patient's legally authorized guardian
  • CONTROLS: In active follow up by a COG institution; active follow up will be defined as date of last visit or contact by a COG institution within the past 24 months; any type of contact, including contact specifically for participation in ALTE03N1, qualifies as active follow-up; please note: treatment on a COG (or legacy group) therapeutic protocol for the primary cancer is NOT required
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082745


  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Smita Bhatia    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Smita Bhatia         
University of Alabama at Birmingham Cancer Center Suspended
Birmingham, Alabama, United States, 35233
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: David L. Becton    501-686-8274      
Principal Investigator: David L. Becton         
University of Arkansas for Medical Sciences Suspended
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455      
Principal Investigator: Robert M. Cooper         
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Saro H. Armenian    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Saro H. Armenian         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas       helpdesk@childrensoncologygroup.org   
Principal Investigator: Leo Mascarenhas         
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Fataneh (Fae) Majlessipour    310-423-8965      
Principal Investigator: Fataneh (Fae) Majlessipour         
Mattel Children's Hospital UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: William A. May       helpdesk@childrensoncologygroup.org   
Principal Investigator: William A. May         
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Pamela H. Kempert    310-825-6708      
Principal Investigator: Pamela H. Kempert         
Children's Hospital and Research Center at Oakland Suspended
Oakland, California, United States, 94609-1809
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Steven K. Bergstrom    510-891-3400      
Principal Investigator: Steven K. Bergstrom         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Sheri L. Spunt    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Sheri L. Spunt         
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: William D. Roberts       helpdesk@childrensoncologygroup.org   
Principal Investigator: William D. Roberts         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly W. Maloney       helpdesk@childrensoncologygroup.org   
Principal Investigator: Kelly W. Maloney         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    800-579-7822      
Principal Investigator: Michael S. Isakoff         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Nina S. Kadan-Lottick    203-785-5702      
Principal Investigator: Nina S. Kadan-Lottick         
United States, Delaware
Alfred I duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Jeffrey S. Dome       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jeffrey S. Dome         
United States, Florida
Lee Memorial Health System Suspended
Fort Myers, Florida, United States, 33901
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Emad K. Salman    877-680-0008      
Principal Investigator: Emad K. Salman         
University of Florida Suspended
Gainesville, Florida, United States, 32610
Nemours Children's Clinic-Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
University of Miami Miller School of Medicine-Sylvester Cancer Center Suspended
Miami, Florida, United States, 33136
Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Enrique A. Escalon       helpdesk@childrensoncologygroup.org   
Principal Investigator: Enrique A. Escalon         
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: Doured Daghistani    800-599-2456    cancerinfo@baptisthealth.net   
Principal Investigator: Doured Daghistani         
Nemours Children's Clinic - Orlando Suspended
Orlando, Florida, United States, 32806
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Scott M. Bradfield       helpdesk@childrensoncologygroup.org   
Principal Investigator: Scott M. Bradfield         
Johns Hopkins All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Peter H. Shaw       helpdesk@childrensoncologygroup.org   
Principal Investigator: Peter H. Shaw         
Saint Joseph's Hospital/Children's Hospital-Tampa Recruiting
Tampa, Florida, United States, 33607
Contact: Mark J. Mogul    704-384-5369      
Principal Investigator: Mark J. Mogul         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Suspended
Atlanta, Georgia, United States, 30322
Augusta University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Colleen H. McDonough    706-721-1663    cancer@augusta.edu   
Principal Investigator: Colleen H. McDonough         
United States, Hawaii
University of Hawaii Cancer Center Suspended
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Wade T. Kyono    808-586-2979      
Principal Investigator: Wade T. Kyono         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Eugenia Chang       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eugenia Chang         
United States, Illinois
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Reggie E. Duerst       helpdesk@childrensoncologygroup.org   
Principal Investigator: Reggie E. Duerst         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Tara O. Henderson    773-834-7424      
Principal Investigator: Tara O. Henderson         
Advocate Children's Hospital-Oak Lawn Suspended
Oak Lawn, Illinois, United States, 60453
Advocate Children's Hospital-Park Ridge Suspended
Park Ridge, Illinois, United States, 60068
Advocate Lutheran General Hospital Suspended
Park Ridge, Illinois, United States, 60068
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Pedro A. De Alarcon    888-226-4343      
Principal Investigator: Pedro A. De Alarcon         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    800-248-1199      
Principal Investigator: Robert J. Fallon         
Saint Vincent Hospital and Health Care Center Suspended
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mariko Sato    800-237-1225      
Principal Investigator: Mariko Sato         
United States, Kansas
University of Kansas Cancer Center Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky/Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lars M. Wagner    859-257-3379      
Principal Investigator: Lars M. Wagner         
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ashok B. Raj    866-530-5516      
Principal Investigator: Ashok B. Raj         
United States, Louisiana
Tulane University Health Sciences Center Suspended
New Orleans, Louisiana, United States, 70112
Children's Hospital New Orleans Suspended
New Orleans, Louisiana, United States, 70118
United States, Maine
Eastern Maine Medical Center Suspended
Bangor, Maine, United States, 04401
United States, Massachusetts
Dana-Farber Cancer Institute Suspended
Boston, Massachusetts, United States, 02215
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Raymond J. Hutchinson       helpdesk@childrensoncologygroup.org   
Principal Investigator: Raymond J. Hutchinson         
Wayne State University/Karmanos Cancer Institute Active, not recruiting
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Hadi Sawaf    313-343-3166      
Principal Investigator: Hadi Sawaf         
Michigan State University Clinical Center Recruiting
East Lansing, Michigan, United States, 48824-7016
Contact: Renuka Gera    517-975-9547      
Principal Investigator: Renuka Gera         
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48502
Contact: Nkechi Onwuzurike    810-762-8057      
Principal Investigator: Nkechi Onwuzurike         
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: David S. Dickens    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: David S. Dickens         
Bronson Methodist Hospital Suspended
Kalamazoo, Michigan, United States, 49007
Kalamazoo Center for Medical Studies Suspended
Kalamazoo, Michigan, United States, 49008
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Michael K. Richards       helpdesk@childrensoncologygroup.org   
Principal Investigator: Michael K. Richards         
University of Minnesota/Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Joseph P. Neglia       helpdesk@childrensoncologygroup.org   
Principal Investigator: Joseph P. Neglia         
Mayo Clinic Suspended
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Gail C. Megason    601-815-6700      
Principal Investigator: Gail C. Megason         
United States, Missouri
Columbia Regional Recruiting
Columbia, Missouri, United States, 65201
Contact: Barbara A. Gruner       helpdesk@childrensoncologygroup.org   
Principal Investigator: Barbara A. Gruner         
University of Missouri - Ellis Fischel Withdrawn
Columbia, Missouri, United States, 65212
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine L. Hetherington       helpdesk@childrensoncologygroup.org   
Principal Investigator: Maxine L. Hetherington         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Robert J. Hayashi         
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Nik Farahana N. Rashid    702-384-0013      
Principal Investigator: Nik Farahana N. Rashid         
Children's Specialty Center of Nevada II Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
Sunrise Hospital and Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Alan K. Ikeda    702-384-0013      
Principal Investigator: Alan K. Ikeda         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Burton E. Appel    201-996-2879      
Principal Investigator: Burton E. Appel         
Saint Barnabas Medical Center Active, not recruiting
Livingston, New Jersey, United States, 07039
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Nibal A. Zaghloul       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nibal A. Zaghloul         
Newark Beth Israel Medical Center Suspended
Newark, New Jersey, United States, 07112
Saint Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mary A. Bonilla         
United States, New Mexico
University of New Mexico Cancer Center Suspended
Albuquerque, New Mexico, United States, 87102
United States, New York
Brooklyn Hospital Center Suspended
Brooklyn, New York, United States, 11201
Maimonides Medical Center Active, not recruiting
Brooklyn, New York, United States, 11219
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Denise A. Rokitka    877-275-7724      
Principal Investigator: Denise A. Rokitka         
NYU Winthrop Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    516-663-3115      
Principal Investigator: Mark E. Weinblatt         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Alice Lee    212-305-8615      
Principal Investigator: Alice Lee         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Charles A. Sklar    212-639-7202      
Principal Investigator: Charles A. Sklar         
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Robert I. Parker    800-862-2215      
Principal Investigator: Robert I. Parker         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Melanie A. Comito    315-464-5476      
Principal Investigator: Melanie A. Comito         
New York Medical College Suspended
Valhalla, New York, United States, 10595
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Suspended
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan G. Kreissman    888-275-3853      
Principal Investigator: Susan G. Kreissman         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas W. McLean    336-713-6771      
Principal Investigator: Thomas W. McLean         
United States, North Dakota
Sanford Broadway Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Contact: Samuel O. Anim    800-437-4010      
Principal Investigator: Samuel O. Anim         
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz       helpdesk@childrensoncologygroup.org   
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Rajaram Nagarajan       helpdesk@childrensoncologygroup.org   
Principal Investigator: Rajaram Nagarajan         
Rainbow Babies and Childrens Hospital Suspended
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mark A. Ranalli         
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Ayman A. El-Sheikh       helpdesk@childrensoncologygroup.org   
Principal Investigator: Ayman A. El-Sheikh         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-8199      
Principal Investigator: Janice F. Olson         
Legacy Emanuel Hospital and Health Center Suspended
Portland, Oregon, United States, 97227
United States, Pennsylvania
Lehigh Valley Hospital - Muhlenberg Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Lydia A. Boateng    484-884-2201      
Principal Investigator: Lydia A. Boateng         
Children's Hospital of Philadelphia Suspended
Philadelphia, Pennsylvania, United States, 19104
Childrens Oncology Group Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Smita Bhatia    626-471-7321    sbhatia@coh.org   
Principal Investigator: Smita Bhatia         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Arthur K. Ritchey       helpdesk@childrensoncologygroup.org   
Principal Investigator: Arthur K. Ritchey         
United States, South Carolina
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Stuart L. Cramer    803-434-3680      
Principal Investigator: Stuart L. Cramer         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nichole L. Bryant         
Greenville Cancer Treatment Center Suspended
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Kayelyn J. Wagner    605-328-1367      
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
East Tennessee State University Active, not recruiting
Johnson City, Tennessee, United States, 37614-0054
East Tennessee Childrens Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais    865-541-8266      
Principal Investigator: Ray C. Pais         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne L. Furman       helpdesk@childrensoncologygroup.org   
Principal Investigator: Wayne L. Furman         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Debra L. Friedman    800-811-8480      
Principal Investigator: Debra L. Friedman         
United States, Texas
Texas Tech University Health Sciences Center-Amarillo Terminated
Amarillo, Texas, United States, 79106
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Nkechi I. Mba       helpdesk@childrensoncologygroup.org   
Principal Investigator: Nkechi I. Mba         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Stanton C. Goldman    972-566-5588      
Principal Investigator: Stanton C. Goldman         
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Patrick J. Leavey    214-648-7097      
Principal Investigator: Patrick J. Leavey         
Cook Children's Medical Center Suspended
Fort Worth, Texas, United States, 76104
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Suspended
Houston, Texas, United States, 77030
M D Anderson Cancer Center Suspended
Houston, Texas, United States, 77030
Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Timothy C. Griffin    800-248-1199      
Principal Investigator: Timothy C. Griffin         
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Gerardo Quezada       helpdesk@childrensoncologygroup.org   
Principal Investigator: Gerardo Quezada         
University of Texas Health Science Center at San Antonio Suspended
San Antonio, Texas, United States, 78229
Scott and White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Guy H. Grayson    254-724-5407      
Principal Investigator: Guy H. Grayson         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Phillip E. Barnette       helpdesk@childrensoncologygroup.org   
Principal Investigator: Phillip E. Barnette         
United States, Vermont
University of Vermont College of Medicine Suspended
Burlington, Vermont, United States, 05405
United States, Virginia
Inova Fairfax Hospital Suspended
Falls Church, Virginia, United States, 22042
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe       helpdesk@childrensoncologygroup.org   
Principal Investigator: Eric J. Lowe         
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Madhu S. Gowda       helpdesk@childrensoncologygroup.org   
Principal Investigator: Madhu S. Gowda         
Carilion Clinic Children's Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson       helpdesk@childrensoncologygroup.org   
Principal Investigator: Mandy M. Atkinson         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: K. Scott Baker       helpdesk@childrensoncologygroup.org   
Principal Investigator: K. Scott Baker         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer       helpdesk@childrensoncologygroup.org   
Principal Investigator: Judy L. Felgenhauer         
United States, West Virginia
West Virginia University Charleston Suspended
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Saint Vincent Hospital Cancer Center Green Bay Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: John R. Hill    920-433-8889    Christy.Gilchrist@hshs.org   
Principal Investigator: John R. Hill         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kenneth B. De Santes    800-622-8922      
Principal Investigator: Kenneth B. De Santes         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Bruce M. Camitta    414-955-4727    MACCCTO@mcw.edu   
Principal Investigator: Bruce M. Camitta         
Australia, Queensland
Royal Brisbane and Women's Hospital Suspended
Herston, Queensland, Australia, 4029
Royal Children's Hospital-Brisbane Suspended
Herston, Queensland, Australia, 4029
Lady Cilento Children's Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Helen Irving       helpdesk@childrensoncologygroup.org   
Principal Investigator: Helen Irving         
Australia, South Australia
Women's and Children's Hospital-Adelaide Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Maria L. Kirby       helpdesk@childrensoncologygroup.org   
Principal Investigator: Maria L. Kirby         
Australia, Victoria
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Jordan R. Hansford       helpdesk@childrensoncologygroup.org   
Principal Investigator: Jordan R. Hansford         
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6008
Contact: Marianne B. Phillips    (08) 9340 8222    catherine.cole@health.wa.gov.au   
Principal Investigator: Marianne B. Phillips         
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Sunil Jayantilal S. Desai    780-407-6615    val.taylor@albertahealthservices.ca   
Principal Investigator: Sunil Jayantilal S. Desai         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: David B. Dix       helpdesk@childrensoncologygroup.org   
Principal Investigator: David B. Dix         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: John J. Doyle    416-813-7654 ext 2027    jason.mcguire@sickkids.ca   
Principal Investigator: John J. Doyle         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Conrad V. Fernandez    902-470-8394      
Principal Investigator: Conrad V. Fernandez         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine       helpdesk@childrensoncologygroup.org   
Principal Investigator: Carol Portwine         
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Mariana P. Silva    613-544-2630      
Principal Investigator: Mariana P. Silva         
Children's Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Shayna M. Zelcer       helpdesk@childrensoncologygroup.org   
Principal Investigator: Shayna M. Zelcer         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Donna L. Johnston       helpdesk@childrensoncologygroup.org   
Principal Investigator: Donna L. Johnston         
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Paul C. Nathan    416-813-7654 ext 2027    jason.mcguire@sickkids.ca   
Principal Investigator: Paul C. Nathan         
Canada, Quebec
The Montreal Children's Hospital of the MUHC Active, not recruiting
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4931      
Principal Investigator: Yvan Samson         
Canada, Saskatchewan
Allan Blair Cancer Centre Suspended
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Christopher Mpofu    306-655-2914      
Principal Investigator: Christopher Mpofu         
Puerto Rico
San Jorge Children's Hospital Recruiting
San Juan, Puerto Rico, 00912
Contact: Luis A. Clavell       helpdesk@childrensoncologygroup.org   
Principal Investigator: Luis A. Clavell         
Switzerland
Swiss Pediatric Oncology Group - Geneva Suspended
Geneva, Switzerland, 1205
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Smita Bhatia, MD MPH Children's Oncology Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00082745     History of Changes
Obsolete Identifiers: NCT00228787
Other Study ID Numbers: ALTE03N1
NCI-2011-03822 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ALTE03N1 ( Other Identifier: Children's Oncology Group )
CDR0000360708 ( Other Identifier: ClinicalTrials.gov )
ALTE03N1 ( Other Identifier: Children's Oncology Group )
ALTE03N1 ( Other Identifier: CTEP )
U10CA095861 ( U.S. NIH Grant/Contract )
U10CA180886 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2004
First Posted: May 19, 2004
Last Update Posted: August 21, 2017
Last Verified: August 2017