NCT07154173 Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer
| NCT ID | NCT07154173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Condition | Rectal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07154173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07154173 currently recruiting?
Yes, NCT07154173 is actively recruiting participants. Contact the research team at zslylib@mail.sysu.edu.cn for enrollment information.
Where is the NCT07154173 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07154173 clinical trial?
NCT07154173 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. The trial plans to enroll 300 participants.