NIH Clinical Center Search the Studies: Study Number, Study Title

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.

--Back to Top--

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


--Back to Top--

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.

--Back to Top--

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

Clinical Trials Number:

NCT01313442

--Back to Top--