Actively Recruiting

Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07154173

Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer

Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-12-31

300

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Pathologically confirmed colorectal cancer
  • Clearly defined clinical staging, including metastatic colorectal cancer (stage M1) and non-metastatic colorectal cancer (stage M0)
  • Expected survival of at least 3 months
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • 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
  • Concurrent severe gastrointestinal diseases such as inflammatory bowel disease
  • Active systemic immune or infectious diseases including severe allergies, rheumatoid arthritis, systemic lupus erythematosus, viral hepatitis, or acquired immunodeficiency syndrome
  • Concurrent unhealed primary malignant tumors
  • Severe organ dysfunction or failure
  • Other conditions deemed unsuitable for the study by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

Actively Recruiting

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Research Team

L

Lu Xiang'en

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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