Gut microbiome clues for colorectal cancer risk, progression, and outcomes
Official title: CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
Run by Gulbenkian Institute for Molecular Medicine · NCT06734156 · Data updated 2026-11-12
This study will try to find whether patterns in stool microbes can mark disease stage, prognosis, or treatment response in people aged 40–74 newly diagnosed with colorectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years to 74 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Gulbenkian Institute for Molecular Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Lisbon, Lisbon District and 1 other locations) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | December 2, 2026 |
| Study ends | December 2, 2029 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT06734156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40 to 74 who are residents of Portugal, have a recent diagnosis of colorectal cancer, and have not yet started any cancer treatment are ideal candidates.
✕Probably not a fit
People younger than 40 or 75 and older, those with a first‑degree family history of CRC, prior inflammatory bowel disease, prior or current CRC treatment, pregnancy, or those unwilling to provide stool samples are not eligible and would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will collect fecal samples from treatment‑naïve patients at diagnosis, after each therapeutic regimen (for example surgery or chemotherapy), and again three years after diagnosis to track changes in the gut microbiome over time. Microbiome profiles will be compared with healthy controls and analyzed alongside clinical, lifestyle, and dietary data, with results stratified by age and sex and with a focus on early‑onset cases. The study is observational and longitudinal, aiming to correlate microbial signatures with overall survival and disease‑free survival. Findings will be used to identify candidate biomarkers for validation in future work.
Why it matters
Potential benefit: If successful, this could identify stool microbiome markers that help detect disease stage, predict outcomes, and inform earlier or more personalized follow-up for colorectal cancer patients, particularly younger adults.
How similar studies have gone: Prior research has shown links between gut microbiota and colorectal cancer, but biomarker validation—especially for early‑onset CRC—is still limited and remains an active area of study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be willing and able to provide written informed consent * Resident in Portugal * Age from 40 to 74 years * Have a recent diagnosis of CRC without initiating any treatment. Exclusion Criteria: * Age \< 40 years or ≥ 75 years * Unable to provide informed consent * Refusal to provide stool samples * Previous or current treatment for CRC * First-degree family history of CRC * Previous diagnosis of inflammatory bowel disease (ulcerative colitis, Crohn's disease or indeterminate colitis), inflammatory bowel syndrome, recurrent infection by Clostridioides difficile * Pregnancy
Where it's running
-
Champalimaud Foundation
Lisbon, Lisbon District, Portugal Recruiting -
Gulbenkian Institute for Molecular Medicine
Lisbon, Lisbon District, Portugal Recruiting
Study contacts
- Principal investigator: Ana S Almeida, PhD — Gulbenkian Institute for Molecular Medicine
- Study coordinator: Ana S Almeida, PhD
- Email: ana.almeida@gimm.pt
- Phone: +351 217999411
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer
This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.
-
Intratumoral oncolytic virus plus immune checkpoint inhibitors in metastatic colorectal, gastric, or liver cancer
Doctors are testing whether injecting an oncolytic virus directly into tumors along with immune checkpoint drugs is safe and may help people with advanced colorectal, gastric, or liver cancer who have tried many treatments.
-
Targeted alpha-radiation therapy for NTSR1-positive tumors using SKL35501/SKL35502
This early-phase trial tests whether a two-part approach—an imaging agent to find NTSR1-expressing tumors and a targeted alpha-ray therapy—can be safely used in adults with certain advanced solid tumors.
-
Pirfenidone plus PD-1 inhibitor with or without targeted radiotherapy for advanced colorectal cancer
This study tests whether combining pirfenidone with a PD-1 inhibitor, with or without hypofractionated radiotherapy, is safe and helps people with unresectable or metastatic pMMR/MSS colorectal cancer who have exhausted standard therapies.
-
VMD-102 in liver cancer and other solid tumors
This study tests VMD-102 to see if it is safe and tolerable and to find the best dose for further study in adults with advanced liver cancer and several other solid tumors.
-
First-in-human imaging study of 68Ga-DFC413 and comparison with 68Ga-NNS309 in solid tumors
This study tests a new radioactive imaging agent, 68Ga-DFC413, to see how it behaves in patients with several solid tumors and compares it to 68Ga-NNS309.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.