RecruitingNCT07154173

Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

300 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is analyzing the gut bacteria (microbiome) in people with colorectal cancer — both those with cancer that has spread (metastatic) and those without spread — to identify patterns that might be linked to cancer progression. Participants provide stool and tissue samples. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed colorectal cancer diagnosis - Your cancer stage has been clearly identified (with or without spread to other organs) - Your expected survival is at least 3 months - You are willing to participate and sign consent **You may NOT be eligible if...** - You used probiotics, antibiotics, or immunosuppressive drugs in the month before surgery - You had a bowel blockage or perforation before surgery - You have had previous abdominal surgery (other than appendectomy, cholecystectomy, or colorectal cancer surgery) - You have active inflammatory bowel disease, immune conditions, or severe organ failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen 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.


Locations(1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT07154173


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