Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer
NCT ID: NCT07154173
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-01-01
2026-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
Biospecimen Collection Procedure
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.
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
Biospecimen Collection Procedure
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.
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
Biospecimen Collection Procedure
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.
Interventions
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Biospecimen Collection Procedure
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Locations
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The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Huai'ming Wang
Role: primary
References
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Wirbel J, Pyl PT, Kartal E, Zych K, Kashani A, Milanese A, Fleck JS, Voigt AY, Palleja A, Ponnudurai R, Sunagawa S, Coelho LP, Schrotz-King P, Vogtmann E, Habermann N, Nimeus E, Thomas AM, Manghi P, Gandini S, Serrano D, Mizutani S, Shiroma H, Shiba S, Shibata T, Yachida S, Yamada T, Waldron L, Naccarati A, Segata N, Sinha R, Ulrich CM, Brenner H, Arumugam M, Bork P, Zeller G. Meta-analysis of fecal metagenomes reveals global microbial signatures that are specific for colorectal cancer. Nat Med. 2019 Apr;25(4):679-689. doi: 10.1038/s41591-019-0406-6. Epub 2019 Apr 1.
Other Identifiers
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MCRCGM-SYSU-2025-01
Identifier Type: -
Identifier Source: org_study_id