Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
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Purpose
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 |
|---|
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Normal and Diseased Tissue and Body Fluids Samples |
| Study Type: | Observational |
| Study Design: | 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 |
- Collecting, processing and archiving human tissue [ Time Frame: Samples will be stored indefinitely. ] [ Designated as safety issue: No ]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
Blood, ascites, pleural effusion, bone marrow, solid tumors, brain tumors, tissue uninvolved by tumor, cerebrospinal fluid, and urine samples. These are kept sterile whenever possible, and cells and tissues are cryopreserved viable. Specimens containing plasma are collected into syringes containing preservative-free heparin to prevent clotting.
| Estimated Enrollment: | 6000 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | January 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Protocol Participants
All participants enrolled on protocols
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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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients and their relatives treated at St. Jude Children's Research Hospital (SJCRH), collaborating sites and affiliates.
Inclusion Criteria:
- Patients (and their relatives) treated at SJCRH and SJCRH affiliates and collaborating sites that have IRB approval for TBANK with malignant and non-malignant conditions.
Exclusion Criteria:
- Patients from institutions that do not have IRB approval for TBANK, or patients not enrolled on SJCRH protocols that incorporate consent for tumor banking.
Contacts and Locations| Contact: Charles Mullighan, MD | 901-595-3387 | charles.mullighan@stjude.org |
| United States, California | |
| 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, Tennessee | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Charles Mulligan, MD 866-278-5833 info@stjude.org | |
| Principal Investigator: Charles Mullighan, 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 | |
| Principal Investigator: | Charles Mullighan, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01354002 History of Changes |
| Other Study ID Numbers: | TBANK |
| Study First Received: | May 9, 2011 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Jude Children's Research Hospital:
|
human biological samples tissue banking |
ClinicalTrials.gov processed this record on June 18, 2013