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

April 23, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • St. Jude Clinic at Huntsville Hospital for Women & Children
        • Contact:
        • Principal Investigator:
          • Marla Daves, 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:
          • Ayobami Olanrewaju, MBBS
    • 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:
        • Principal Investigator:
          • Christine Bolen, MD
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • St. Jude Affiliate Clinic at Saint Francis Children's Hospital
        • Contact:
        • Principal Investigator:
          • Ashraf Mohamed, MD, MHA, PhD
    • 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
        • Principal Investigator:
          • Charles Mullighan, MBBS, MD
        • Contact:
      • Memphis, Tennessee, United States, 38103
        • Recruiting
        • LeBonheur Children's Hospital
        • Principal Investigator:
          • Charles Mullighan, MBBS, MD
        • Contact:
          • Charles Mullighan, MBBS, MD
          • Phone Number: 901-287-5437
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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).
  • Samples from employees of St. Jude Children's Research Hospital (SJCRH) collected for public health surveillance studies (e.g. SJTRC-NCT04362995) provided the employees have consented to participate in the specific IRB-approved studies.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Protocol Participants
All participants enrolled on protocols

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Jude Children's Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2050

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2050

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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