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Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets


N/A
16 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Cancer, Liver Cancer, Pancreatic Cancer, Melanoma

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Trial Information

Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets


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

Inclusion 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Udai S Kammula, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

120175

NCT ID:

NCT01658917

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Gastrointestinal Cancer
  • Liver Cancer
  • Pancreatic Cancer
  • Melanoma
  • Tissue Acquisition
  • Liver Neoplasms
  • Melanoma
  • Pancreatic Neoplasms
  • Gastrointestinal Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892