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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01354002
First received: May 9, 2011
Last updated: May 12, 2014
Last verified: May 2014
  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
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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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
Protocol Participants
All participants enrolled on protocols

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
Study Population

All patients and their relatives treated at St. Jude Children's Research Hospital (SJCRH), collaborating sites and affiliates.

Criteria

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.
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354002

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

Locations
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         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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 12, 2014
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 October 23, 2014