NCT07154173Recruiting
Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 27 Aug 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07154173
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Jan 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of probiotics, antibiotics, or immunosuppressive agents within 1 month before surgery
- 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
Other illness
- Preoperative complete intestinal obstruction or gastrointestinal perforation
- Intraoperative gastrointestinal perforation or tumor rupture
- Severe organ dysfunction or failure
- Other conditions deemed unsuitable for this study by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.