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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01313442
Recruitment Status : Recruiting
First Posted : March 11, 2011
Last Update Posted : June 5, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- 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.

Condition or disease
Non-GI Cancers Cancer of Gastrointestinal Tract Gastrointestinal Cancer

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 diseases 2-4 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, tumor tissue or stool samples may be collected from consenting subjects at the initial visit and/or at the time of visit to NIH, scheduled per other NIH protocols.
  • Analysis of subject s samples include but not limited to immune-monitoring, single cell sequencing, identifying of gene expression and generation of CAR-T cells.
  • Stool samples will be used to determine the intestinal microbiome.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer
Actual Study Start Date : March 2, 2011

1/ Cohort 1
Subjects with a diagnosis of cancer

Primary Outcome Measures :
  1. Collected samples [ Time Frame: 10 years ]
    Collected blood, normal tissue, tumor samples from patients with gastrointestinal (GI) cancers being reviewed by Medical Oncology Branch and to perform immune studies.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Clinical
  • Patients 18 years of age and older
  • Patients with a diagnosis of cancer
  • Patients must be able to understand and willing to sign a written informed consent document



Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01313442

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Contact: Santhana B Webb, R.N. (240) 858-3165
Contact: Tim F Greten, M.D. (240) 760-6114

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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)
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Principal Investigator: Tim F Greten, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT01313442    
Other Study ID Numbers: 110112
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: May 29, 2020

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Studies a U.S. FDA-regulated Drug Product: No
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:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases