Gut and tumor bacteria patterns in metastatic versus non-metastatic colorectal cancer
Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer
This project will test whether bacteria in the gut and tumor differ between people whose colorectal cancer has spread and those whose cancer has not to see if bacterial signatures can help predict spread.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07154173 on ClinicalTrials.gov |
What this trial studies
This observational study will collect tumor tissue, adjacent normal tissue, metastasis tissue when present, and preoperative stool from adults with pathologically confirmed colorectal cancer. Samples will undergo metagenomic and microbiome profiling to identify bacterial species and functional signatures. Investigators will compare microbial patterns between patients with metastatic (M1) and non‑metastatic (M0) disease to look for differences and potential predictive markers. Enrollment is single‑center at the Sixth Affiliated Hospital of Sun Yat‑sen University and excludes patients with recent antibiotics/probiotics or major concurrent immune/infectious conditions.
Who should consider this trial
Good fit: Adults 18–75 with pathologically confirmed colorectal cancer, clear staging as M0 or M1, expected survival of at least three months, and willingness to provide tissue and stool samples are the ideal candidates.
Not a fit: Patients who recently used antibiotics, probiotics, or immunosuppressants, have severe active systemic immune or infectious diseases, or cannot provide the required samples are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could reveal bacterial markers that help predict which colorectal cancers are likely to spread and inform personalized monitoring or treatment strategies.
How similar studies have performed: Previous studies have linked specific bacteria (for example Fusobacterium) to colorectal cancer progression, but using microbiome signatures to reliably predict metastasis remains experimental and not yet established clinically.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 75 years * Pathologically confirmed colorectal cancer * Clearly defined clinical staging: including imaging or pathologically confirmed metastatic colorectal cancer (stage M1) and colorectal cancer without distant metastasis (stage M0) * Expected survival ≥ 3 months * Voluntary participation and signed informed consent Exclusion Criteria: * Use of probiotics, antibiotics, or immunosuppressive agents within 1 month before surgery * Preoperative complete intestinal obstruction or gastrointestinal perforation * Intraoperative gastrointestinal perforation or tumor rupture * Previous history of gastrointestinal surgery (excluding colorectal cancer surgery, appendectomy, and cholecystectomy) or concurrent severe gastrointestinal diseases such as inflammatory bowel disease * Concurrent active systemic immune or infectious diseases, including severe allergies, rheumatoid arthritis, systemic lupus erythematosus, viral hepatitis, acquired immunodeficiency syndrome, etc. * Concurrent unhealed primary malignant tumors * Severe organ dysfunction or failure * Other conditions deemed unsuitable for this study by the investigator
Where this trial is running
Guangzhou, Guangdong
- The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lu Xiang'en
- Email: zslylib@mail.sysu.edu.cn
- Phone: +86-020-38379764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.