Collecting Solid Tumor Tissue to Identify New Treatments
- Researchers are looking at different types of cancerous tissues to study new treatments. They are looking at solid tumors of the esophagus, stomach, liver, gall bladder, intestines, and other organs. Tumor and other tissue samples will be collected for study. Researchers also want to collect information on the operations used to obtain tumor samples. These samples will be used to develop new cancer treatments.
- To collect solid tumor and normal tissue samples to investigate new cancer therapies.
- Individuals at least 16 years of age who have precancerous or cancerous solid tumors.
- Participants will have surgery or biopsy to collect tumor samples for study.
- Participants will provide blood samples before having the surgery or biopsy. Some may have leukapheresis to collect extra white blood cells for study.
- During the surgery or biopsy, pieces of the tumor or growth will be collected. Some normal tissue near the tumor will also be collected.
- Information on the cancer and the surgery will also be collected.
- Treatment will not be provided as part of this study.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets|
- 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: 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
- 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
- Secondary Objectives: To collect detailed history, demographic, treatment data, and perioperative findings in order to categorize and track the specific procedures and outcomes.
- Patients greater than or equal to 16 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658917
|Contact: June Kryk, R.N.||(301) firstname.lastname@example.org|
|Contact: Udai S Kammula, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center 866-820-4505 firstname.lastname@example.org|
|Principal Investigator:||Udai S Kammula, M.D.||National Cancer Institute (NCI)|