Trial record 1 of 2 for:    COG AAML08B1
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Study of Blood Samples From Newborns With Down Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00959283
First received: August 13, 2009
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

RATIONALE: Studying the genes expressed in samples of blood from patients with Down syndrome may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples from newborns with Down syndrome.


Condition Intervention
Leukemia
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: flow cytometry
Other: laboratory biomarker analysis
Other: pharmacological study

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biology Study of Transient Myeloproliferative Disorder (TMD) in Children With Down Syndrome (DS)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Event-free survival [ Time Frame: length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Transient myeloproliferative disorder (TMD)-related mortality [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • Incidence of subsequent leukemia for patients with resolved TMD [ Time Frame: length of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood


Estimated Enrollment: 180
Study Start Date: February 2009
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To further our biological understanding of the natural history of transient myeloproliferative disorder (TMD) and its relationship to subsequent leukemia by facilitating the development of a TMD cell and protein bank, and repository of DNA/RNA from megakaryoblasts for future biological studies.
  • To investigate the biology of TMD molecular changes associated with resolution of TMD or its conversion to acute myeloid leukemia within each mortality-risk group by conducting GATA1 mutational analyses, hematopoiesis clonality studies, assessment of RAS mutations, and genomic instability studies using glycophorin A assays.
  • To determine if high-resolution microarray genomic analysis of TMD blasts (using Affymetrix SNP Genechip technology to assess gene expression, copy number variation, and loss of heterozygosity) can predict the development of subsequent leukemia.
  • To determine the relationship of minimal residual disease (monitored by peripheral blood flow cytometry and GATA1 mutational studies) to clinical remission status and development of subsequent leukemia within each mortality-risk group of TMD patients.
  • To evaluate the relationship between karyotype (including FISH analysis) and subsequent leukemia in TMD patients.
  • To examine pharmacogenetics and in vitro drug sensitivity to cytarabine (MTT assay) in blasts from TMD patients.
  • To examine the relationship of functional polymorphisms in Phase I and Phase II drug detoxification genes, DNA repair, and DNA synthesis pathways that may modify susceptibility to leukemia and outcome in TMD patients.
  • To determine the relationship between fibrosis-associated serum factors (e.g., platelet-derived growth factor, transforming growth factor beta, N-terminal peptide of III procollagen, type IV collagen, and hyaluronic acid) and event-free survival.

OUTLINE: This is a multicenter study.

Patients undergo peripheral blood collection periodically for biomarker analysis. Samples are analyzed for GATA1 mutations by real-time PCR, polymorphisms, cytogenetics, - and K-RAS mutations, gene expression, drug sensitivity patterns, and minimal residual disease by flow cytometry.

Patients are followed up periodically for 5 years.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

See Eligibility criteria.

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of transient myeloproliferative disorder (TMD) at < 90 days of age and meeting 1 of the following criteria:

    • A diagnosis of Down syndrome or Down syndrome mosaicism AND non-erythroid and non-lymphoid blasts (any amount) in the peripheral blood verified with a second sample

      • Patients with typical physical characteristics of Down syndrome are allowed before cytogenetic or FISH confirmation of the diagnosis
    • Trisomy 21-positive leukemic blasts documented by biopsy of any organ (including > 5% non-erythroid/non-lymphoid blasts documented by bone marrow aspirate or biopsy)

      • Infants with isolated trisomy 21 positivity identified only in the leukemic blasts are allowed
  • Institutional immunophenotype characterization is required for study enrollment

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959283

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center    205-934-0309      
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36604
Contact: Felicia L. Wilson    251-405-5115      
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016-7710
Contact: Jessica Boklan    602-546-0920      
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni    501-686-8274      
United States, California
Loma Linda University Cancer Institute at Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Clinical Trials Office - Loma Linda University Cancer Institut    909-558-3375      
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Recruiting
Long Beach, California, United States, 90801
Contact: Amanda M. Termuhlen    562-933-8605      
Southern California Permanente Medical Group Recruiting
Los Angeles, California, United States, 90027
Contact: Robert M. Cooper    323-783-5307      
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-2529      
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048-1865
Contact: Fataneh (Fae) Majlessipour    310-423-4423      
Children's Hospital Central California Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse    559-353-5480      
Children's Hospital and Research Center Oakland Recruiting
Oakland, California, United States, 94609
Contact: Clinical Trial Office - Children's Hospital and Research Cente    510-450-7600      
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Violet Shen    714-532-8636      
Lucile Packard Children's Hospital at Stanford University Medical Center Recruiting
Palo Alto, California, United States, 95798
Contact: Neyssa M. Marina    650-723-5535      
Sutter Cancer Center Recruiting
Sacramento, California, United States, 95816
Contact: Clinical Trial Office - Sutter Cancer Center    916-454-6595      
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer    916-734-3089      
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123-4282
Contact: Clinical Trials Office - Rady Children's Hospital - San Diego    858-966-5934      
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi    877-827-3222      
United States, Colorado
Children's Hospital Colorado Center for Cancer and Blood Disorders Recruiting
Aurora, Colorado, United States, 80045
Contact: Kelly W. Maloney    720-777-6673      
Presbyterian - St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen    303-839-6000      
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Clinical Trials Office - Connecticut Children's Medical Center    860-545-9967      
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Clinical Trials Office - Yale Cancer Center    203-785-5702      
United States, Delaware
Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre    302-651-5755      
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center    202-444-0381      
United States, Florida
Lee Cancer Care of Lee Memorial Health System Recruiting
Fort Myers, Florida, United States, 33901
Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt    877-680-0008      
Memorial Cancer Institute at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Clinical Trials Office - Memorial Cancer Institute    954-985-3443      
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Eric S. Sandler    904-697-3793      
Nemours Children's Clinic - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Ramamoorthy Nagasubramanian    407-650-7230      
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute    407-303-5623      
M.D. Anderson Cancer Center at Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-8588      
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Jeffrey H. Schwartz    850-505-4790      
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-4176      
St. Joseph's Cancer Institute at St. Joseph's Hospital Recruiting
Tampa, Florida, United States, 33607
Contact: Clinical Trials Office - St. Joseph's Cancer Institute    800-882-4123      
Kaplan Cancer Center at St. Mary's Medical Center Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Narayana Gowda    561-844-6363      
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Recruiting
Atlanta, Georgia, United States, 30322
Contact: Todd M. Cooper    404-785-1838      
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403-3089
Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer    912-350-8568      
United States, Hawaii
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii    808-586-2979      
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center Recruiting
Boise, Idaho, United States, 83712-6297
Contact: Eugenia Chang    208-381-2731      
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
Children's Memorial Hospital - Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Stewart Goldman    312-227-4844      
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612-7243
Contact: Clinical Trial Office - University of Illinois Cancer Center    312-355-3046      
Keyser Family Cancer Center at Advocate Hope Children's Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Ammar Hayani    708-684-4094      
Simmons Cooper Cancer Institute Recruiting
Springfield, Illinois, United States, 62794-9677
Contact: Clinical Trials Office - Simmons Cooper Cancer Institute    217-545-7929      
United States, Indiana
Riley's Children Cancer Center at Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: James M. Croop    317-944-8784      
St. Vincent Indianapolis Hospital Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital    317-338-2194      
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Clinical Trials Office - Blank Children's Hospital    515-241-6729      
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service    800-237-1225      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40232
Contact: Clinical Trials Office - Kosair Children's Hospital    502-629-5500    CancerResource@nortonhealthcare.org   
United States, Louisiana
Tulane Cancer Center Office of Clinical Research Recruiting
Alexandria, Louisiana, United States, 71315-3198
Contact: Clinical Trials Office - Tulane Cancer Center    504-988-6121      
Children's Hospital of New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Clinical Trials Office - Children's Hospital of New Orleans    504-894-5377      
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Clinical Trials Office - CancerCare of Maine    207-973-4274      
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce    410-955-8804    jhcccro@jhmi.edu   
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Recruiting
Baltimore, Maryland, United States, 21215
Contact: Joseph M. Wiley    410-601-6266      
National Naval Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Melissa A. Forouhar    253-968-6144      
United States, Massachusetts
Floating Hospital for Children at Tufts - New England Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Johannes E. Wolff    617-636-5535      
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109-0286
Contact: Clinical Trials Office - C.S. Mott Children's Hospital    800-865-1125      
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute    313-576-9363      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center    810-762-8057      
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Clinical Trials Office - Helen DeVos Children's Hospital    616-391-3050      
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo    313-343-3166      
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007-5381
Contact: Jeffrey S. Lobel    269-341-6350      
Breslin Cancer Center at Ingham Regional Medical Center Recruiting
Lansing, Michigan, United States, 48910
Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio    517-334-2765      
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Clinical Trials Office - Children's Hospitals and Clinics of M    612-813-5193      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, Mississippi
University of Mississippi Cancer Clinic Recruiting
Jackson, Mississippi, United States, 39216-4505
Contact: Gail C. Megason    601-984-5220      
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center    573-882-7440      
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine L. Hetherington    816-234-3265      
David C. Pratt Cancer Center at St. John's Mercy Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J    314-251-6770      
Cardinal Glennon Children's Hospital Recruiting
St. Louis, Missouri, United States, 63104
Contact: William S. Ferguson    314-577-5638      
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi    314-454-2041      
United States, Nebraska
Children's Hospital Recruiting
Omaha, Nebraska, United States, 68114-4113
Contact: Minnie Abromowitch    402-955-3950      
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ    800-999-5465      
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89109-2306
Contact: Jonathan Bernstein    702-732-1493      
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center    603-650-7609    cancerhelp@dartmouth.edu   
United States, New Jersey
Hackensack University Medical Center Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center    201-996-2879      
St. Barnabas Medical Center Cancer Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Clinical Trials Office - St. Barnabas Medical Center Cancer Ce    973-322-2470      
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Stanley Calderwood    732-745-6674      
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey    732-235-8675      
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Clinical Trials Office - Newark Beth Israel Medical Center    973-926-3136      
St. Joseph's Hospital and Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Mary A. Bonilla    973-754-3349      
Carol G. Simon Cancer Center at Morristown Memorial Hospital Recruiting
Summit, New Jersey, United States, 07901
Contact: Steven L. Halpern    973-971-6720      
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente    505-272-6972      
United States, New York
Albany Medical Center Hospital Recruiting
Albany, New York, United States, 12208-3419
Contact: Vikramjit S. Kanwar    518-262-5513 ext 25517      
Albert Einstein Cancer Center at Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe    718-904-2730    aecc@aecom.yu.edu   
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute    877-275-7724      
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Mark E. Weinblatt    516-663-9400      
Schneider Children's Hospital Recruiting
New Hyde Park, New York, United States, 11040
Contact: Arlene S. Redner    718-470-3460      
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C    212-305-8615      
NYU Cancer Institute at New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Linda Granowetter    212-263-8400      
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jeffrey R. Andolina    585-275-2981      
Stony Brook University Cancer Center Recruiting
Stony Brook, New York, United States, 11794-9446
Contact: Clinical Trials Office - Stony Brook University Cancer Center    800-862-2215      
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi    315-464-5476      
United States, North Carolina
Mission Hospitals - Memorial Campus Recruiting
Asheville, North Carolina, United States, 28801
Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus    828-213-4150      
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente    877-668-0683      
Contact    919-966-4432      
Presbyterian Cancer Center at Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28233-3549
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt    704-384-5369      
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas    704-355-2884      
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Cancer Institute    888-275-3853      
Leo W. Jenkins Cancer Center at ECU Medical School Recruiting
Greenville, North Carolina, United States, 27834
Contact: Clinical Trials Office - Leo W. Jenkins Cancer Center at ECU M    252-744-2391      
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, North Dakota
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Nathan L. Kobrinsky    701-234-7544      
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308-1062
Contact: Clinical Trials Office - Akron Children's Hospital    330-543-3193      
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica    513-636-2799      
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106-5000
Contact: Yousif (Joe) H. Matloub    216-844-3345      
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205-2696
Contact: Laura T. Martin    614-722-3582      
Dayton Children's - Dayton Recruiting
Dayton, Ohio, United States, 45404-1815
Contact: Emmett H. Broxson    937-641-3111      
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Clinical Trials Office - Toledo Hospital    419-824-1842      
Mercy Children's Hospital Recruiting
Toledo, Ohio, United States, 43608
Contact: Rama Jasty    419-251-8215      
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-5311      
Natalie Warren Bryant Cancer Center at St. Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Gregory B. Kirkpatrick    918-502-6720      
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea    503-494-1080    trials@ohsu.edu   
Legacy Emanuel Children's Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Clinical Trials Office - Legacy Emanuel Children's Hospital    503-413-2560      
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Lisa M. McGregor    717-531-6012      
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Fox    267-425-3010      
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh    412-692-7056      
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C    401-444-1488      
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni    843-792-9321      
Palmetto Health South Carolina Cancer Center Recruiting
Columbia, South Carolina, United States, 29203
Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer    803-434-3680      
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center    605-328-1367      
United States, Tennessee
T.C. Thompson Children's Hospital Recruiting
Chattanooga, Tennessee, United States, 37403
Contact: Manoo G. Bhakta    423-778-7289      
East Tennessee Children's Hospital Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais    865-541-8266      
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Clinical Trials Office - St. Jude Children's Research Hospital    901-595-4644      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
United States, Texas
Texas Tech University Health Sciences Center School of Medicine - Amarillo Recruiting
Amarillo, Texas, United States, 79106
Contact: Osvaldo Regueira    806-354-5434 ext 282      
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: Clinical Trials Office - Driscoll Children's Hospital    361-694-5311      
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a    866-460-4673      
Contact    214-648-7097      
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Carl Lenarsky    972-566-6647 ext 4439      
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234-6200
Contact: Clinical Trials Office - Brooke Army Medical Center    210-916-4837      
Cook Children's Medical Center - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Contact: Clinical Trials Office - Cook's Children's Medical Center    682-885-2103      
Baylor University Medical Center - Houston Recruiting
Houston, Texas, United States, 77030-2399
Contact: Patrick A. Thompson    832-824-4029      
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Anne-Marie R. Langevin    210-567-7477      
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84113-1100
Contact: Phillip E. Barnette    801-662-4700      
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care    802-656-8990      
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kimberly P. Dunsmore    434-924-5105      
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042-3300
Contact: Clinical Trials Office - Inova Fairfax Hospital    703-208-6650      
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507-1971
Contact: Eric J. Lowe    757-668-7243      
Carilion Medical Center for Children at Roanoke Community Hospital Recruiting
Roanoke, Virginia, United States, 24014
Contact: Mandy M. Atkinson    540-981-7376      
United States, Washington
Children's Hospital and Regional Medical Center - Seattle Recruiting
Seattle, Washington, United States, 98105
Contact: Julie R. Park    206-987-2106      
Providence Cancer Center at Sacred Heart Medical Center Recruiting
Spokane, Washington, United States, 99220-2555
Contact: Judy L. Felgenhauer    509-474-2777      
Mary Bridge Children's Hospital and Health Center - Tacoma Recruiting
Tacoma, Washington, United States, 98405
Contact: Robert G. Irwin    253-403-3481      
United States, West Virginia
West Virginia University Health Sciences Center - Charleston Recruiting
Charleston, West Virginia, United States, 25302
Contact: Allen R. Chauvenet    304-388-1552      
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael E. Kelly    414-456-4170      
Australia, Victoria
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Francoise M. Mechinaud    613-9345-4893      
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6001
Contact: Catherine H. Cole    011-6189340-8238      
Canada, British Columbia
Children's and Women's Hospital of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Caron Strahlendorf    604-875-3576      
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Rochelle A. Yanofsky    204-787-4163      
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Lisa Anne B. Goodyear    709-777-4303      
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Contact: Margaret C. Yhap    902-470-8778      
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine    905-521-2100x73464      
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Mariana P. Silva    613-5496666x3833      
Children's Hospital of Western Ontario Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Anne E Cairney    519-685-8494      
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Jacqueline M Halton    613-737-7600 ext 2370      
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Sylvain Baruchel    416-813-7795      
Canada, Quebec
Montreal Children's Hospital at McGill University Health Center Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish    514-412-4400x22219      
Hopital Sainte Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4931x2790      
Canada
Centre Hospitalier Universitaire de Quebec Recruiting
Quebec, Canada, G1V 4G2
Contact: Bruno Michon    418-656-4141X47191      
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: April D. Sorrell, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00959283     History of Changes
Other Study ID Numbers: AAML08B1, COG-AAML08B1, CDR0000636115
Study First Received: August 13, 2009
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Oncology Group:
acute myeloid leukemia/transient myeloproliferative disorder

Additional relevant MeSH terms:
Down Syndrome
Leukemia
Leukemoid Reaction
Myeloproliferative Disorders
Abnormalities, Multiple
Bone Marrow Diseases
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Hematologic Diseases
Intellectual Disability
Leukocyte Disorders
Leukocytosis
Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on October 28, 2014