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Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility

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.
 
ClinicalTrials.gov Identifier: NCT01354002
Recruitment Status : Recruiting
First Posted : May 16, 2011
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief Summary:
The aims of this protocol are: to collect and store diseased and normal tissue and body fluid samples from new and returning patients at St. Jude Children's Research Hospital (SJCRH), affiliated sites and collaborating institutions; to collect and store samples from relatives of SJCRH patients; to collect and store retrospective and prospective pertinent corresponding clinical and laboratory data on disease characterization, treatment, and outcome; and to serve as a source of human biological samples and corresponding laboratory and clinical data.

Condition or disease
Normal and Diseased Tissue and Body Fluids Samples

Detailed Description:
There is no study design for this protocol. Samples obtained under IRB/IEC-approved protocols that clearly permit storage of patient material at SJCRH will be banked, provided proof of informed consent is available. Such samples will be tagged accordingly and will be only released to fulfill the aim(s) of the protocol under which they were obtained, or to investigators that apply to the St. Jude Children's Research Hospital Tissue Resources Committee to use the samples.

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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
Actual Study Start Date : September 1, 2009
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


Group/Cohort
Protocol Participants
All participants enrolled on protocols



Primary Outcome Measures :
  1. Collecting, processing and archiving human tissue [ Time Frame: Samples will be stored indefinitely. ]
    Human tissue and body fluids will be collected for use in research; The processing of samples helps to reduce duplication of technical effort, equipment, supplies, and laboratory space by investigators requiring human tissues for research


Biospecimen Retention:   Samples With DNA
Samples collected and processed from patients include any tumor or non-tumor sample, including blood, ascites, pleural effusion, bone marrow, solid tumors, brain tumors, tissue uninvolved by tumor, cerebrospinal fluid, and urine samples. Non-tumor samples are also collected and processed from patients' relatives and controls. Samples are processed under sterile conditions whenever possible, and tumor cells and tissues are cryopreserved viable. Cellular subfractions are also isolated including DNA, RNA, and protein.


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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients, their relatives, and control populations treated at St. Jude Children's Research Hospital (SJCRH), collaborating sites and affiliates.
Criteria

Inclusion Criteria:

  • Patients (and their relatives) and control populations treated or studied at SJCRH and SJCRH affiliates and collaborating sites that have IRB approval for TBANK with malignant and non-malignant conditions.
  • Patients from institutions that do not have Institutional Review Board (IRB) approval for TBANK, and at which a banking mechanism may not be established, who provide samples for research at St. Jude and from whom consent for TBANK is obtained by the TBANK principal investigator (PI).

Exclusion Criteria:

  • Patients from institutions that do not have IRB approval for TBANK, and who have not provided consent for TBANK, or patients not enrolled on SJCRH protocols that incorporate consent for tumor banking.

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): NCT01354002


Contacts
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Contact: Charles Mullighan, MBBS, MD 901-595-3387 charles.mullighan@stjude.org

Locations
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United States, Alabama
Huntsville Hospital for Women & Children Recruiting
Huntsville, Alabama, United States, 35801
Contact: Carolyn Russo, MD    256-265-5833      
Principal Investigator: Carolyn Russo, MD         
United States, California
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Norman J. Lacayo, MD    650-723-5535    lacayon@stanford.edu   
Principal Investigator: Norman J. Lacayo, MD         
Rady Children's Hospital and Health Center Recruiting
San Diego, California, United States, 92123
Contact: Deborah Schiff, MD    858-966-5983      
Principal Investigator: Deborah Schiff, MD         
United States, Illinois
Children's Hospital of Illinois at OSF-Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Mary Beth Ross, MD    309-624-4945      
Principal Investigator: Mary Beth Ross, MD         
United States, Louisiana
Our Lady of the Lake Regional Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Jeffrey Deyo, MD    225-763-6337      
Principal Investigator: Jeffrey Deyo, MD         
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Jeffrey Taub, MD    313-745-5515      
Principal Investigator: Jeffrey Taub, MD         
United States, Missouri
Mercy Children's Hospital - Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Francisca R. Fasipe, MD    877-700-2110      
Principal Investigator: Francisca R. Fasipe, MD         
United States, North Carolina
St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Randy Hock, MD    800-786-1638      
Principal Investigator: Randy Hock, MD         
United States, Oklahoma
St. Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Gregory B. Kirkpatrick, MD    918-494-2200    gbkirkpatrick@saintfrancis.com   
Principal Investigator: Gregory B. Kirkpatrick, MD         
United States, Tennessee
Johnson City Medical Center Recruiting
Johnson City, Tennessee, United States, 37604
Contact: Marcela Popescu, MD    423-431-3950      
Principal Investigator: Marcela Popescu, MD         
LeBonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Richard Boop, MD    901-287-5437      
Principal Investigator: Richard Boop, MD         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Charles Mulligan, MBBS, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Charles Mullighan, MBBS, MD         
United States, Texas
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Kenneth M. Heym, MD    682-885-4007      
Principal Investigator: Kenneth M. Heym, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Charles Mullighan, MBBS, MD St. Jude Children's Research Hospital
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01354002    
Other Study ID Numbers: TBANK
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
human biological samples
tissue banking