Collecting Solid Tumor Tissue to Identify New Treatments
|ClinicalTrials.gov Identifier: NCT01658917|
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : February 14, 2018
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
This study will allow tissue samples obtained during the protocol screening process to be used for future and ongoing research in the NCI Surgery Branch
Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment Protocol
Patients will undergo testing and evaluations as required by the appropriate NCI Surgery Branch Treatment protocol
|Condition or disease|
|Gastrointestinal Cancer Liver Cancer Pancreatic Cancer Melanoma|
- Recent advances and insights into the molecular pathogenesis of cancer have led to the development of novel molecular and biologic targeted therapies for the treatment of advanced cancer patients. A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies.
- The Surgery Branch, NCI has an interest in identifying novel molecular and biologic targets to facilitate the development of future cancer therapies. In addition, we have the primary responsibility for providing surgical consultative services to the NIH. As such, we are uniquely positioned to acquire and perform important studies on solid tumor tissue to help identify therapeutic targets that may have significant clinical ramifications.
- Primary Objective: To collect biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets
- Patients greater than or equal to 18 years of age with radiographic evidence of, biochemical evidence of, or histologically/cytologically proven solid neoplasms who require diagnostic or therapeutic intervention as a part of the diagnosis and /or standard of care treatment and/or follow up for their neoplasm
- Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to planned intervention
- A tissue acquisition trial in which tissues will be obtained at the time of intervention
- Tissue and blood will be processed at the time of collection, stored and then transferred to Dr. Kammula s laboratory for further processing.
- No investigational therapy will be given.
- It is anticipated that 1000 patients will be enrolled over a period of 10 years
|Study Type :||Observational|
|Actual Enrollment :||133 participants|
|Official Title:||Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets|
|Study Start Date :||July 19, 2012|
Patients >=18 years of age who have premalignant, primary or metastatic solid tumors based upon either radiographic or biochemical testing, or histological/cytological analysis
- To collect biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets [ Time Frame: at time of surgery or biospy ]To collect biologic samples from patients undergoing diagnostic ortherapeutic interventions for premalignant, primary or metastaticsolid tumors for the purpose of identifying novel molecular andbiologic therapeutic targets
- To collect detailed history, demographic, treatment data, and perioperative findings in order to categorize and track the specific procedures and outcomes. [ Time Frame: at time of consent ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658917
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute (NCI)|