Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01313442
First received: March 10, 2011
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

Background:

- Gastrointestinal cancers can occur in the throat, stomach, gallbladder, liver, pancreas, and colon. Researchers are interested in evaluating how active the immune system is in trying to fight the cancer by studying blood and tumor tissue donated from individuals who have been diagnosed with gastrointestinal cancers.

Objectives:

- To collect blood and tumor samples from individuals who have been diagnosed with gastrointestinal cancers in order to study the immune system s response to the cancer.

Eligibility:

- Individuals at least 18 years of age who have been diagnosed with throat, stomach, gallbladder, liver, pancreatic, or colon cancer, and are scheduled to be treated at the National Institutes of Health.

Design:

  • The study will require at least one but no more than four visits to the National Institutes of Health Clinical Center.
  • Participants will be screened with a physical examination and medical history, and will provide a baseline blood sample for study.
  • Participants will provide additional blood samples 2 and 4 months after the baseline sample, as well as a final sample at the completion of the treatment protocol.
  • Participants will provide tumor tissue samples only if they undergo a surgical procedure related to the treatment for their gastrointestinal cancer.
  • No treatment will be provided as part of this protocol.

Condition
Gastrointestinal Neoplasms
Cancer of Gastrointestinal Tract
Cancer of the Gastrointestinal Tract
Gastrointestinal Cancer
Neoplasms, Gastrointestinal

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer

Resource links provided by NLM:


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

Estimated Enrollment: 500
Study Start Date: February 2011
Detailed Description:

BACKGROUND:

  • Numerous recent therapeutic advances have changed standard treatment options for patients with GI cancer. These include newer chemotherapeutic agents in addition to established proof of principle for anti-angiogenic agents. The burden of GI cancers is reflected by the presence of three GI cancer types in the top five causes of cancer mortality. Over 58,000 deaths yearly can be attributed to GI cancer.
  • While immune-based therapies in GI cancers are experimental at the current time, a gathering body of literature is suggestive of an enormous potential, either alone, or most likely in combination with standard chemotherapy.
  • Before immunotherapy can be combined with non-immune based treatment options we first need to investigate the effects of non-immune based therapies on immune responses (especially immune-evasive mechanisms) with cancer.

OBJECTIVES:

  • To collect blood and/or tumor samples, including pleural and peritoneal fluid, from patients with gastrointestinal (GI) cancers being reviewed by Medical Oncology Branch and to perform an analysis of immune subsets with regard to their function and how they modulate with therapy. Also to collect from patients with non-GI cancers for comparison.
  • To identify new immune suppressor mechanisms
  • To collect blood samples from both patients with GI cancer and also age-matched healthy controls for exploratory quantitative and qualitative analysis of circulating tumor cells (CTC assay).

ELIGIBILITY:

  • Patients undergoing evaluation for participation in NCI treatment protocols in the NCI intramural program with diagnosis of cancer.
  • 18 year of age or older.

DESIGN:

  • Blood and/or tumor samples may be collected from consenting subjects at the initial visit and/or at follow-up visits.
  • Analysis of immune function will be performed both at baseline, and at subsequent visits, if they have follow up at NIH, at up to two additional time points when the patient returns for follow-up, and end of therapy.
  • Blood will also be obtained from patients and healthy controls for CTC analysis.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Patients 18 years of age and older
  • Patients with a diagnosis of cancer
  • Patients must be willing to provide informed consent

EXCLUSION CRITERIA:

-Children less than 18 years old are not eligible

  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: NCT01313442

Contacts
Contact: Suzanne Fioravanti, R.N. (301) 594-6544 fioravas@mail.nih.gov
Contact: Tim F Greten, M.D. (301) 451-4723 gretentf@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 National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Tim F Greten, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01313442     History of Changes
Other Study ID Numbers: 110112, 11-C-0112
Study First Received: March 10, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Tissue Acquisition
Gastrointestinal Cancer
Immune Suppressor
Immune Monitoring
Samples
Gastrointestinal Tract Cancer

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014