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

NCT ID: NCT01354002

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-01

Study Completion Date

2050-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Normal and Diseased Tissue and Body Fluids Samples

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Protocol Participants

All participants enrolled on protocols

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Mullighan, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Clinic at Huntsville Hospital for Women & Children

Huntsville, Alabama, United States

Site Status RECRUITING

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Rady Children's Hospital and Health Center

San Diego, California, United States

Site Status RECRUITING

Children's Hospital of Illinois at OSF-Saint Francis Medical Center

Peoria, Illinois, United States

Site Status RECRUITING

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

Site Status RECRUITING

Louisiana State University Health Sciences Center

Shreveport, Louisiana, United States

Site Status RECRUITING

Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status SUSPENDED

Mercy Children's Hospital - Springfield

Springfield, Missouri, United States

Site Status RECRUITING

St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital

Charlotte, North Carolina, United States

Site Status RECRUITING

St. Jude Affiliate Clinic at Saint Francis Children's Hospital

Tulsa, Oklahoma, United States

Site Status RECRUITING

Johnson City Medical Center

Johnson City, Tennessee, United States

Site Status RECRUITING

LeBonheur Children's Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Charles Mullighan, MBBS, MD

Role: CONTACT

901-595-3387

Facility Contacts

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Marla Daves, MD

Role: primary

256-265-5833

Norman J. Lacayo, MD

Role: primary

650-723-5535

Deborah Schiff, MD

Role: primary

858-966-5983

Mary Beth Ross, MD

Role: primary

309-624-4945

Jeffrey Deyo, MD

Role: primary

225-763-6337

Ayobami Olanrewaju, MBBS

Role: primary

318-626-0772

Francisca R. Fasipe, MD

Role: primary

877-700-2110

Christine Bolen, MD

Role: primary

704-384-1900

Ashraf Mohamed, MD, MHA, PhD

Role: primary

918-851-1924

Marcela Popescu, MD

Role: primary

423-431-3950

Charles Mullighan, MBBS, MD

Role: primary

901-287-5437

Charles Mulligan, MBBS, MD

Role: primary

866-278-5833

Kenneth M. Heym, MD

Role: primary

682-885-4007

References

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Maciaszek JL, Oak N, Chen W, Hamilton KV, McGee RB, Nuccio R, Mostafavi R, Hines-Dowell S, Harrison L, Taylor L, Gerhardt EL, Ouma A, Edmonson MN, Patel A, Nakitandwe J, Pappo AS, Azzato EM, Shurtleff SA, Ellison DW, Downing JR, Hudson MM, Robison LL, Santana V, Newman S, Zhang J, Wang Z, Wu G, Nichols KE, Kesserwan CA. Enrichment of heterozygous germline RECQL4 loss-of-function variants in pediatric osteosarcoma. Cold Spring Harb Mol Case Stud. 2019 Oct 23;5(5):a004218. doi: 10.1101/mcs.a004218. Print 2019 Oct.

Reference Type DERIVED
PMID: 31604778 (View on PubMed)

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

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TBANK

Identifier Type: -

Identifier Source: org_study_id

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