NCT01313442

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
Last Updated

April 24, 2026

Status Verified

April 15, 2026

First QC Date

March 10, 2011

Last Update Submit

April 23, 2026

Conditions

Cancer of Gastrointestinal TractNon-GI CancersGastrointestinal Cancer

Keywords

Gut MicrobiotaAnalysis of immune subsets with regard to their functionSamplesNatural HistoryGastrointestinal CancerGastrointestinal Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • Collected samples

    Collected blood, tumor samples from participants with gastrointestinal (GI) cancers being reviewed by Medical Oncology Branch and to perform immune studies

    10 years

Study Arms (1)

1/ Cohort 1

Individuals with a diagnosis of cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Clinical

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

  • Greten TF, Ormandy LA, Fikuart A, Hochst B, Henschen S, Horning M, Manns MP, Korangy F. Low-dose cyclophosphamide treatment impairs regulatory T cells and unmasks AFP-specific CD4+ T-cell responses in patients with advanced HCC. J Immunother. 2010 Feb-Mar;33(2):211-8. doi: 10.1097/CJI.0b013e3181bb499f.

    PMID: 20139774BACKGROUND

  • Goldszmid RS, Trinchieri G. The price of immunity. Nat Immunol. 2012 Oct;13(10):932-8. doi: 10.1038/ni.2422. Epub 2012 Sep 18.

    PMID: 22990891BACKGROUND

  • Iida N, Dzutsev A, Stewart CA, Smith L, Bouladoux N, Weingarten RA, Molina DA, Salcedo R, Back T, Cramer S, Dai RM, Kiu H, Cardone M, Naik S, Patri AK, Wang E, Marincola FM, Frank KM, Belkaid Y, Trinchieri G, Goldszmid RS. Commensal bacteria control cancer response to therapy by modulating the tumor microenvironment. Science. 2013 Nov 22;342(6161):967-70. doi: 10.1126/science.1240527.

    PMID: 24264989BACKGROUND

Related Links

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Tim F Greten, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie N Hicks

CONTACT

(240) 760-6159hickssn2@nih.gov

Tim F Greten, M.D.

CONTACT

(240) 760-6114gretentf@mail.nih.gov

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 11, 2011

Study Start

March 2, 2011

Last Updated

April 24, 2026

Record last verified: 2026-04-15

Data Sharing

IPD Sharing
Will share

All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access Criteria
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US(1)