Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer

Recruiting now

Conditions studied: Rectal Neoplasms, Colon Neoplasms, Microbiota, Metagenome

In brief

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

Key facts

Study ID

NCT07154173

Run by

Sixth Affiliated Hospital, Sun Yat-sen University

People needed

300

Starts

2025-01-01

Expected to finish

2026-12-31

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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