Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
This study will enroll patients aged 18-75 years with pathologically confirmed colorectal cancer treated at the Sixth Affiliated Hospital of Sun Yat-sen University. Participants will be divided into two main groups: those with peritoneal metastasis (metastasis group) and those without distant metastasis (non-metastasis group). The study population will include both male and female patients who meet all inclusion criteria and none of the exclusion criteria. All participants must have clearly defined clinical staging and be scheduled for surgical treatment, with an expected survival of at least 3 months. Patients with recent use of antibiotics, probiotics, or immunosuppressants, those with intestinal obstruction or perforation, and those with other severe comorbidities will be excluded.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Biospecimen Collection Procedure
Procedure/SurgeryCollection 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.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: HC1 intervention
Group B: nmCRC1 intervention
Group C: mCRC1 intervention
Trial outcomes
Primary outcomes
1
Intestinal Microbiota Diversity Differences Between Colorectal Cancer Patients With and Without Peritoneal Metastasis
Comparison of microbial diversity between metastasis and non-metastasis groups, including alpha diversity (Chao1 index for species richness, Shannon index for species diversity) and beta diversity (Bray-Curtis distance, UniFrac distance). These measurements will evaluate differences in intestinal microbiota composition related to colorectal cancer peritoneal metastasis.
Time frame
Fecal samples collected at patient's first hospital admission; tissue specimens collected during surgery. All specimens analyzed within 6 months after collection.Sponsors and contacts
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Source ClinicalTrials.gov