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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 October 2016 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: October 11, 2016
Last verified: October 2016
  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
Samples collected and processed from patients include any tumor or non-tumor sample, including blood, ascites, pleural effusion, bone marrow, solid tumors, brain tumors, tissue uninvolved by tumor, cerebrospinal fluid, and urine samples. Non-tumor samples are also collected and processed from patients' relatives and controls. Samples are processed under sterile conditions whenever possible, and tumor cells and tissues are cryopreserved viable. Cellular subfractions are also isolated including DNA, RNA, and protein.

Estimated Enrollment: 100000
Study Start Date: September 2009
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2030 (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:   Child, Adult, Senior
Genders Eligible for Study:   Both
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.
Criteria

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.
  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, MBBS, MD 901-595-3387 charles.mullighan@stjude.org

Locations
United States, Alabama
Huntsville Hospital for Women & Children Recruiting
Huntsville, Alabama, United States, 35801
Contact: Carolyn Russo, MD    256-265-5833      
Principal Investigator: Carolyn Russo, MD         
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, Illinois
Children's Hospital of Illinois at OSF-Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Mary Beth Ross, MD    309-624-4945      
Principal Investigator: Mary Beth Ross, MD         
United States, Louisiana
Our Lady of the Lake Regional Medical Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Jeffrey Deyo, MD    225-763-6337      
Principal Investigator: Jeffrey Deyo, MD         
United States, Missouri
Mercy Children's Hospital - Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Francisca R. Fasipe, MD    877-700-2110      
Principal Investigator: Francisca R. Fasipe, MD         
United States, North Carolina
St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Randy Hock, MD    800-786-1638      
Principal Investigator: Randy Hock, MD         
United States, Tennessee
Johnson City Medical Center Recruiting
Johnson City, Tennessee, United States, 37604
Contact: Marcela Popescu, MD    423-431-3950      
Principal Investigator: Marcela Popescu, MD         
LeBonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38103
Contact: Richard Boop, MD    901-287-5437      
Principal Investigator: Richard Boop, MD         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Charles Mulligan, MBBS, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Charles Mullighan, MBBS, 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, MBBS, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
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: October 11, 2016
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 December 09, 2016