Protocol Details

Acquisition of Blood and Tumor Tissue Samples from Patients with Gastrointestinal Cancer

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	11-C-0112
Sponsoring Institute	National Cancer Institute (NCI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Children
Keywords	Gut Microbiota; Analysis of immune subsets with regard to their function; Samples; Natural History
Recruitment Keyword(s)	Gastrointestinal Cancer; Gastrointestinal Tract Cancer
Condition(s)	Non-GI Cancers; Cancer of Gastrointestinal Tract; Gastrointestinal Cancer
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA:

-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

EXCLUSION CRITERIA:

None

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Citations:

Greten TF, Ormandy LA, Fikuart A, H(SqrRoot)(Delta)chst B, Henschen S, H(SqrRoot)(Delta)rning 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.

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.

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.

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Contacts:

Principal Investigator	Referral Contact	For more information:
Tim F. Greten, M.D. National Cancer Institute (NCI) NIHBC 10 - CLINICAL CENTER BG RM 2B38B 10 CENTER DR BETHESDA MD 20892 (240) 760-6114 gretentf@mail.nih.gov	Stephanie N. Hicks National Cancer Institute (NCI) National Institutes of Health Building 10 Room 4-3152 10 Center Drive Bethesda, Maryland 20892 (240) 760-6159 hickssn2@nih.gov	NCI Referral Office National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office 1-888-NCI-1937 ncimo_referrals@mail.nih.gov

Clinical Trials Number:

NCT01313442

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