Protocol for Collecting, Banking and Distributing Human Tissue Samples: St. Jude Children's Research Hospital Tissue Resources Core Facility
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| ClinicalTrials.gov Identifier: NCT01354002 |
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Recruitment Status :
Recruiting
First Posted : May 16, 2011
Last Update Posted : November 8, 2019
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Sponsor:
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
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Brief Summary:
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 or disease |
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| Normal and Diseased Tissue and Body Fluids Samples |
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 : | Observational |
| Estimated Enrollment : | 100000 participants |
| 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 |
| Actual Study Start Date : | September 1, 2009 |
| Estimated Primary Completion Date : | December 2030 |
| Estimated Study Completion Date : | December 2030 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Health Facilities
| Group/Cohort |
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Protocol Participants
All participants enrolled on protocols
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Primary Outcome Measures :
- 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
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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| Lucile Packard Children's Hospital Stanford University | Recruiting |
| Palo Alto, California, United States, 94305 | |
| Contact: Norman J. Lacayo, MD 650-723-5535 lacayon@stanford.edu | |
| Principal Investigator: Norman J. Lacayo, MD | |
| 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, Michigan | |
| Children's Hospital of Michigan | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Jeffrey Taub, MD 313-745-5515 | |
| Principal Investigator: Jeffrey Taub, 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, Oklahoma | |
| St. Francis Hospital | Recruiting |
| Tulsa, Oklahoma, United States, 74136 | |
| Contact: Gregory B. Kirkpatrick, MD 918-494-2200 gbkirkpatrick@saintfrancis.com | |
| Principal Investigator: Gregory B. Kirkpatrick, 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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01354002 |
| Other Study ID Numbers: |
TBANK |
| First Posted: | May 16, 2011 Key Record Dates |
| Last Update Posted: | November 8, 2019 |
| Last Verified: | November 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by St. Jude Children's Research Hospital:
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human biological samples tissue banking |