Meta-analysis of fecal metagenomes reveals global microbial signatures that are specific for colorectal cancer.
Jakob Wirbel, Paul Theodor Pyl, Ece Kartal...
https://pubmed.ncbi.nlm.nih.gov/30936547Actively Recruiting
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID07154173
Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-12-31
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer is a common and serious disease that often spreads to other parts of the body. This research focuses on understanding how bacteria in the gut and within tumors may affect the spread of colorectal cancer. Investigators aim to discover differences in bacteria between patients whose cancer has spread and those whose cancer has not, and whether certain bacteria can help predict cancer spread. Participants are divided into groups including healthy individuals, patients with colorectal cancer without distant metastasis, and patients with metastatic colorectal cancer. Samples collected include stool samples, tumor tissue, normal tissue near tumors, and tissue from metastatic sites. These samples will be analyzed to compare bacterial patterns among the groups. During the study, participants will provide stool samples and tissue samples during surgery if applicable. Researchers will study the diversity of intestinal bacteria using advanced testing. The main measurement is the difference in microbiota diversity between patients with and without peritoneal metastasis. All specimens are collected and analyzed within six months after surgery. Participation involves sample collection and may last throughout the surgical and initial hospital admission period.
CONDITIONS
Brief Title
Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer
Who Can Participate
Age: 18Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Pathologically confirmed colorectal cancer
- Clearly defined clinical staging including metastatic (M1) and non-metastatic (M0) colorectal cancer
- Expected survival of 3 months or more
- Voluntary participation with signed informed consent
You will not qualify if you...
- Use of probiotics, antibiotics, or immunosuppressive drugs within 1 month before surgery
- Complete intestinal obstruction or gastrointestinal perforation before surgery
- Gastrointestinal perforation or tumor rupture during surgery
- History of gastrointestinal surgery except colorectal cancer surgery, appendectomy, or gallbladder removal
- Severe gastrointestinal diseases such as inflammatory bowel disease
- Active systemic immune or infectious diseases including severe allergies, rheumatoid arthritis, lupus, viral hepatitis, or AIDS
- Unhealed primary malignant tumors
- Severe organ dysfunction or failure
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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 - At hospital admission and during surgery if applicable
Participants provide fecal samples at their first hospital admission. Operable colorectal cancer patients also provide tumor and adjacent normal tissue samples during surgery for research analysis.
1 to 2 visits depending on surgery scheduling
Specimen Analysis Observation
Duration - Up to 6 months after sample collection
All collected fecal and tissue specimens are analyzed within 6 months after collection to study gut microbiota signatures.
No additional visits required
Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
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Research Team
L
Lu Xiang'en
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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