NCT01313442

Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer

Recruiting now Last updated 2 March 2026

What this trial tests

trial in Non-GI Cancers in 550 participants. Currently enrolling.

Timeline

2 March 2011

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	550
Start date	2 March 2011
Sites	1 location across United States

Conditions studied

• Non-GI Cancers — all drugs for Non-GI Cancers →
• Cancer of Gastrointestinal Tract — all drugs for Cancer of Gastrointestinal Tract →
• Gastrointestinal Cancer — all drugs for Gastrointestinal Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Non-GI Cancers or Cancer of Gastrointestinal Tract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Single-cell atlas of tumor cell evolution in response to therapy in hepatocellular carcinoma and intrahepatic cholangiocarcinoma.
   Ma L, Wang L, Khatib SA, Chang CW, et al · · 2021 · cited 266× · PMID 34216724 · DOI 10.1016/j.jhep.2021.06.028
2. Tumor-associated macrophages trigger MAIT cell dysfunction at the HCC invasive margin.
   Ruf B, Bruhns M, Babaei S, Kedei N, et al · · 2023 · cited 135× · PMID 37595566 · DOI 10.1016/j.cell.2023.07.026
3. Gut microbiota: impacts on gastrointestinal cancer immunotherapy.
   Lau HCH, Sung JJ, Yu J. · · 2021 · cited 42× · PMID 33435800 · DOI 10.1080/19490976.2020.1869504
4. Humoral IgG1 responses to tumor antigens underpin clinical outcomes in immune checkpoint blockade.
   Gonzalez-Kozlova E, Sweeney R, Figueiredo I, Tuballes K, et al · · 2026 · cited 1× · PMID 41593194 · DOI 10.1038/s41591-025-04177-6