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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 1, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) Identifier:
First received: March 10, 2011
Last updated: August 4, 2017
Last verified: August 1, 2017


- 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.


- 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.


- 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.


  • 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.

Non-GI Cancers Cancer of Gastrointestinal Tract Gastrointestinal Cancer

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

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

Primary Outcome Measures:
  • Collected blood, normal tissue, tumor samples from patients withgastrointestinal (GI) cancers being reviewed by Medical OncologyBranch and to perform immune studies [ Time Frame: 10 years ]

Estimated Enrollment: 500
Study Start Date: February 23, 2011
Detailed Description:


  • 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.
  • Commensal gut microbiota play an important role in colonic inflammation and colon cancer. The human gut flora consists of approximately 100 trillion microbial cells, which their disruption leads to many types of diseases including inflammatory bowel disease and colorectal cancer. Recent studies have shown that colon cancer patients as well other patients with gastrointestinal cancers have an altered gut flora when compared to healthy controls. As an example, intestinal microbiome has been shown to contribute to the start and progression of certain kinds of liver diseases such as NAFLD as well as end-stage liver diseases1-3 Therefore, it is important to investigate further as to how the gut affects the patient s response to chemotherapy, other types of cancer therapy and to tumor growth in general.


To serve as an umbrella protocol to allow collection, storage and investigation of samples from patients with gastrointestinal (GI) cancers in support of Thoracic and GI Oncology Branch translational trials to develop new therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic models. Also, to collect samples from patients with non-GI cancers for comparison.


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


  • 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 circulating tumor cells (CTC) analysis.
  • Stool samples will be obtained to determine the intestinal microbiome.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Patients 18 years of age and older
  • Patients with a diagnosis of cancer
  • Patients must be willing to provide informed consent


  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 identifier: NCT01313442

Contact: Suzanne Fioravanti, R.N. (240) 760-6113
Contact: Tim F Greten, M.D. (301) 451-4723

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
National Cancer Institute (NCI)
Principal Investigator: Tim F Greten, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT01313442     History of Changes
Other Study ID Numbers: 110112
Study First Received: March 10, 2011
Last Updated: August 4, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gut Microbiota
Analysis of immune subsets with regard to their function
Gastrointestinal Cancer
Gastrointestinal Tract Cancer

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases processed this record on September 21, 2017