Low-dose cyclophosphamide treatment impairs regulatory T cells and unmasks AFP-specific CD4+ T-cell responses in patients with advanced HCC.
Tim F Greten, Lars A Ormandy, Annika Fikuart...
https://pubmed.ncbi.nlm.nih.gov/20139774Actively Recruiting
Age: 18Years +
All Genders
ID01313442
Acquisition of Data, Blood, and Tumor Tissue Samples From Patients With Gastrointestinal Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-29
550
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the immune system responds to gastrointestinal cancers, which include cancers in the throat, stomach, gallbladder, liver, pancreas, and colon. This observational study focuses on collecting blood and tumor samples from adults diagnosed with these cancers to better understand immune activity and how it may interact with various treatments. The study also explores the role of gut bacteria in cancer progression and response to therapy. Participants will have between one and four visits to the National Institutes of Health Clinical Center. They will undergo a physical exam, medical history review, and provide blood samples at baseline, two months, four months, and at the end of their treatment protocol. Tumor tissue samples are collected only if participants have surgery related to their cancer treatment. No treatment is given as part of this study. During the study, participants will provide blood and, if applicable, tumor tissue and stool samples for analysis. Researchers will study immune responses, gene expression, and the intestinal microbiome. The primary outcome is collecting these samples over a period of up to 10 years. Participants will be monitored through scheduled visits and sample collections, but their usual cancer treatment continues independently of this protocol.
CONDITIONS
Brief Title
Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Sample Collection
Duration - Up to 10 years
Participants provide blood, tumor tissue, or stool samples for analysis to support research on gastrointestinal cancers and related therapies.
Visits scheduled per other NIH protocols when participants visit NIH
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
S
Stephanie N Hicks
T
Tim F Greten, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The price of immunity.
Romina S Goldszmid, Giorgio Trinchieri
https://pubmed.ncbi.nlm.nih.gov/22990891Commensal bacteria control cancer response to therapy by modulating the tumor microenvironment.
Noriho Iida, Amiran Dzutsev, C Andrew Stewart...
https://pubmed.ncbi.nlm.nih.gov/24264989