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

October 9, 2023 updated by: St. Jude Children's Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Huntsville Hospital for Women & Children
        • Contact:
          • Carolyn Russo, MD
          • Phone Number: 256-265-5833
        • Principal Investigator:
          • Carolyn Russo, MD
    • California
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Lucile Packard Children's Hospital Stanford University
        • Contact:
        • Principal Investigator:
          • Norman J. Lacayo, MD
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital and Health Center
        • Contact:
          • Deborah Schiff, MD
          • Phone Number: 858-966-5983
        • Principal Investigator:
          • Deborah Schiff, MD
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • Children's Hospital of Illinois at OSF-Saint Francis Medical Center
        • Contact:
          • Mary Beth Ross, MD
          • Phone Number: 309-624-4945
        • Principal Investigator:
          • Mary Beth Ross, MD
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake Regional Medical Center
        • Contact:
          • Jeffrey Deyo, MD
          • Phone Number: 225-763-6337
        • Principal Investigator:
          • Jeffrey Deyo, MD
      • Shreveport, Louisiana, United States, 71130-3932
        • Recruiting
        • Louisiana State University health Sciences Center
        • Contact:
        • Principal Investigator:
          • John Vanchiere, MD, PhD
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Suspended
        • Children's Hospital of Michigan
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Children's Hospital - Springfield
        • Contact:
          • Francisca R. Fasipe, MD
          • Phone Number: 877-700-2110
        • Principal Investigator:
          • Francisca R. Fasipe, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital
        • Contact:
          • Randy Hock, MD
          • Phone Number: 800-786-1638
        • Principal Investigator:
          • Randy Hock, MD
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • St. Francis Hospital
        • Contact:
        • Principal Investigator:
          • Gregory B. Kirkpatrick, MD
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Recruiting
        • Johnson City Medical Center
        • Contact:
          • Marcela Popescu, MD
          • Phone Number: 423-431-3950
        • Principal Investigator:
          • Marcela Popescu, MD
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St. Jude Children's Research Hospital
        • Contact:
        • Principal Investigator:
          • Charles Mullighan, MBBS, MD
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • Lebonheur Children's Hospital
        • Contact:
          • Richard Boop, MD
          • Phone Number: 901-287-5437
        • Principal Investigator:
          • Richard Boop, MD
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Cook Children's Medical Center
        • Contact:
          • Kenneth M. Heym, MD
          • Phone Number: 682-885-4007
        • Principal Investigator:
          • Kenneth M. Heym, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Protocol Participants
All participants enrolled on protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Samples will be stored indefinitely.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Charles Mullighan, MBBS, MD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2009

Primary Completion (Estimated)

December 1, 2050

Study Completion (Estimated)

December 1, 2050

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 12, 2011

First Posted (Estimated)

May 16, 2011

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TBANK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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