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.
Normal and Diseased Tissue and Body Fluids Samples
|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|
- 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 With DNA as well as Samples Without DNA will be retained.
All samples that are collected and processed, including cryopreserved tumor cells, non-tumor fractions isolated from tumor samples (plasma, serum); and non-tumor samples collected from patients, controls and relatives; and cellular sub-fractions isolated from samples including DNA, RNA and protein.
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. These are kept sterile whenever possible, and tumor cells and tissues are cryopreserved viable where possible. Specimens containing plasma are collected into syringes containing preservative-free heparin to prevent clotting.
|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)|
All participants enrolled on protocols
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354002
|Contact: Charles Mullighan, MBBS, MDfirstname.lastname@example.org|
|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, MBBS, MD 866-278-5833 email@example.com|
|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|
|Principal Investigator:||Charles Mullighan, MBBS, MD||St. Jude Children's Research Hospital|