Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer
Colorectal cancer (CRC) is one of the most common and deadly cancers worldwide. About 1 in 4 people with CRC already have cancer spread (metastasis) when first diagnosed, and about half develop spread during their illness. Recent research shows that bacteria living in the gut and even within tumors might play an important role in how cancer spreads.
The goal of this study is to better understand how bacteria might influence the spread of colorectal cancer. The main questions the investigators aim to answer are:
Are there differences in bacteria between people whose cancer has spread and those whose cancer has not spread? Could certain bacteria help predict which cancers might spread?
To answer these questions, the investigators will:
Collect different types of samples from participants:
Tumor tissue Normal tissue near the tumor Tissue from where cancer has spread Stool samples before surgery Study the bacteria in these samples using advanced testing methods Compare bacterial patterns between different groups
People can take part in this study if they:
Are between 18 and 75 years old Have colorectal cancer confirmed by doctors Have not taken antibiotics recently Do not have immune system problems
This research may help us:
Understand why some colorectal cancers spread Find new ways to predict which cancers might spread Develop better treatments for colorectal cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lu Xiang'en
- Phone Number: +86-020-38379764
- Email: zslylib@mail.sysu.edu.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510655
- Recruiting
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Contact:
- Huai'ming Wang
- Phone Number: +86-020-38254052
- Email: wanghm7@mail.sysu.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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HC
Healthy individuals without colorectal cancer or other cancers Will provide stool samples Matched by age and gender with cancer groups
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Collection of fecal samples from healthy volunteers, non-metastatic (M0) and metastatic (M1) colorectal cancer patients.
Additionally, collection of tissue samples during surgery from operable patients (M0 and M1) for subsequent research analysis.
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nmCRC
Participants with colorectal cancer without distant metastasis (M0 stage) Confirmed by imaging studies and/or pathological examination Will provide primary tumor tissue, adjacent normal tissue, and stool samples
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Collection of fecal samples from healthy volunteers, non-metastatic (M0) and metastatic (M1) colorectal cancer patients.
Additionally, collection of tissue samples during surgery from operable patients (M0 and M1) for subsequent research analysis.
|
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mCRC
Participants with colorectal cancer with distant metastasis (M1 stage) Confirmed by imaging studies and/or pathological examination Will provide primary tumor tissue, metastatic tumor tissue, adjacent normal tissue, and stool samples
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Collection of fecal samples from healthy volunteers, non-metastatic (M0) and metastatic (M1) colorectal cancer patients.
Additionally, collection of tissue samples during surgery from operable patients (M0 and M1) for subsequent research analysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intestinal Microbiota Diversity Differences Between Colorectal Cancer Patients With and Without Peritoneal Metastasis
Time Frame: Fecal samples collected at patient's first hospital admission; tissue specimens collected during surgery. All specimens analyzed within 6 months after collection.
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Comparison of microbial diversity between metastasis and non-metastasis groups, including alpha diversity (Chao1 index for species richness, Shannon index for species diversity) and beta diversity (Bray-Curtis distance, UniFrac distance).
These measurements will evaluate differences in intestinal microbiota composition related to colorectal cancer peritoneal metastasis.
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Fecal samples collected at patient's first hospital admission; tissue specimens collected during surgery. All specimens analyzed within 6 months after collection.
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCRCGM-SYSU-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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