Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT01313442

Conditions

Non-GI Cancers

Cancer of Gastrointestinal Tract

Gastrointestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Non-GI Cancers

Cancer of Gastrointestinal Tract

Gastrointestinal Cancer

Study ID

NCT01313442

Start date

Mar 2, 2011

Status verified date

Aug 19, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • Individuals 18 years of age and older
  • Individuals with a diagnosis of cancer
  • Individuals must be able to understand and willing to sign a written informed consent document

EXCLUSION CRITERIA:

-None

Study Design

Enrollment

550 participants

Anticipated

Interventions and Outcome Measures

Arms

1/ Cohort 1

Individuals with a diagnosis of cancer

Primary outcome measure

  • Collected samples [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 27, 2026

Last verified

Aug 19, 2026

Keywords

  • Gut Microbiota
  • Analysis of immune subsets with regard to their function
  • Samples
  • Natural History
  • Gastrointestinal Cancer
  • Gastrointestinal Tract Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-27.