Collecting Solid Tumor Tissue to Identify New Treatments
Conditions
Gastrointestinal Cancer - Liver Cancer - Pancreatic Cancer - Melanoma
Conditions: official terms
Gastrointestinal Neoplasms - Pancreatic Neoplasms
Conditions: Keywords
Tissue Acquisition
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Overall Status
Recruiting
Summary
Background:

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.

Objective:

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

Eligibility:

Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment Protocol

Design

Patients will undergo testing and evaluations as required by the appropriate NCI Surgery Branch Treatment protocol

...
Detailed Description
BACKGROUND:

- 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.

OBJECTIVES:

- 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.

ELIGIBILITY:

- 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

DESIGN:

- 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 16 Years
Gender: Both
Criteria: - INCLUSION CRITERIA:

- Patients must be greater than or equal to 16 years of age.

- Patients who have a premalignant, primary or metastatic solid tumors based upon either radiographic or biochemical testing, or histological/cytological analysis that requires surgery or biopsy as a part of the standard of care diagnosis, treatment and/or follow up

- Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.

- Patients must be planning to undergo surgery or biopsy as part of their treatment plan. Note: Patients will not be enrolled exclusively for the procurement of tissue samples.

- Patients who agree to undergo leukapheresis must meet the following criteria:

- Seronegative for HIV

- Seronegative for hepatitis B surface antigen and seronegative for

antibody to hepatitis C.

- CBC within normal limits
Location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Status: Recruiting
Contact: For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center - 866-820-4505 - ncisbirc@mail.nih.gov
Start Date
July 2012
Sponsors
National Cancer Institute (NCI)
Source
National Institutes of Health Clinical Center (CC)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page