Protocol Details
Acquisition of Data, Blood, and Tumor Tissue Samples from Patients with Gastrointestinal Cancer
This study is currently recruiting participants.
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.
Eligibility
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
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.
Contacts:
Clinical Trials Number:
NCT01313442