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Collecting Solid Tumor Tissue to Identify New Treatments

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01658917
First received: August 3, 2012
Last updated: November 11, 2014
Last verified: March 2014
  Purpose

Background:

- 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.

Objectives:

- To collect solid tumor and normal tissue samples to investigate new cancer therapies.

Eligibility:

  • 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.

Design:

  • 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.

Condition
Gastrointestinal Cancer
Liver Cancer
Pancreatic Cancer
Melanoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: July 2012
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
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658917

Contacts
Contact: June Kryk, R.N. (301) 451-1929 ncisbirc@mail.nih.gov
Contact: Udai S Kammula, M.D. (301) 435-8606 kammulau@mail.nih.gov

Locations
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    ncisbirc@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Udai S Kammula, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01658917     History of Changes
Other Study ID Numbers: 120175, 12-C-0175
Study First Received: August 3, 2012
Last Updated: November 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Tissue Acquisition

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Liver Neoplasms
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Gastrointestinal Diseases
Liver Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014