Gut and tumor bacteria patterns in metastatic versus non-metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.