Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapse

Study Overview
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Brief Summary
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Colonic microbiome has been found to contribute to the development of colorectal cancer. We speculate that gut microbiota related to colorectal cancer relapse after curative treatment. This study aim to discover if any difference of gut microbiota exist in patients who suffer from cancer relapse compared with patients who do not. Finally develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Detailed Description
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Treatments for colorectal cancer of all stages have evolved considerably over the past two decades, resulting in improved long-term outcomes. After curative treatment, however, 30% of patients with stage I-III and up to 65% of patients with stage IV colorectal cancer develop recurrent disease. The human colon plays host to a diverse and metabolically complex community of microorganisms. While the colonic microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that gut microbiota related to colorectal cancer relapse after curative treatment. Patients are routinely offered surveillance in order to detect disease recurrence at an early, asymptomatic stage, with the intention of improving survival. Nevertheless, controversy continues to surround the optimal surveillance protocols. Investigators aim to discover if any difference of gut microbiota is exist in patients who suffer from relapse compared with patients who do not. Future surveillance after colorectal cancer treatment should focus on risk-stratification and should incorporate current knowledge on risk of recurrence in relation to the biology of the tumour as well as gut microbiota feature. Finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Official Title
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Structural of the Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapses After Curative Surgery

Conditions
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Gut Microbiota, Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requirements of informed consent and assent of participant, parent or legal guardian as applicable Patients with colorectal cancer scheduled for radical coloproctectomy and between the age of 18 and 75 years old without considering sex. Patients with BMI= 18.5-23.9 Participants can follow the visit plan Exclusion Criteria: Patients with colorectal cancer with distant metastasis Chronic renal diseases and hepatic cirrhosis Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months Individuals with a history of Chronic diarrhea Individuals with a history of Diabetes mellitus Individuals with a history of Hypertension Individuals with a history of autoimmune diseases Use of antibiotics and probiotics 3 mouth before samples collection Individuals with a history of abdominal operation due to any reason Individuals with any history of cancer other than colorectal cancer Individuals with Inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapse<br>Patients who suffered colorectal cancer relapse after curative surgery | |
| Remission<br>Patients who get remission after curative surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptional changes in gut microbiota | 16S rRNA gene sequencing will be performed with stander procedure | Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epigenetic changes | DNA methylation levels are analysed at baseline and after probiotics use in tissue samples | Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, colorectal cancer, relapse, surveillance