Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and medical history will be collected. Sample analysis will involve simultaneous characterization of host and microbiota genomic and transcriptomic components.

Official Title
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Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma

Conditions
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Colorectal Adenoma and Carcinoma

Intervention / Treatment
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* Procedure: Colon biopsies


Participation Criteria
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Eligibility Criteria
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Lower GI endoscopy patients Inclusion Criteria: Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed Male or female, aged 18 years or above Referred to lower GI endoscopy. Referral reasons can be among others: Positive FOBT (Fecal Occult Blood Test) Follow up after polypectomy Screening because of age Bleeding Abdominal pain Familial or past history of colon cancer or adenoma Abnormal imaging such as barium enema Change in bowel habits Both self-referrals, referrals from external GP or specialists and internal referrals can be included. Exclusion Criteria: Previous diagnosis of an inflammatory bowel disease Previous diagnosis of intestinal polyposis syndrome CRC patients Inclusion criteria: Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed Male or female, aged 18 years or above Diagnosis of CRC for which resection is planned Both internal and external referrals from specialists can be included Exclusion Criteria: Previous diagnosis of an inflammatory bowel disease Previous diagnosis of intestinal polyposis syndrome

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy control<br>Patients undergoing lower GI endoscopy without any colorectal adenoma or carcinoma. | Procedure: Colon biopsies<br> <br> |
| Adenoma<br>Patients undergoing lower GI endoscopy with presence of colorectal adenoma detected. | Procedure: Colon biopsies<br> <br> |
| Colorectal cancer<br>Patients diagnosed with colorectal cancer and referred to surgical carcinoma resection. | Procedure: Colon biopsies<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential host microbiome composition and abundance in healthy, adenoma and CRC patients and its correlation to CRC risk features and host genomic and transcriptomic components. | Host microbiome composition and abundance data will be generated from saliva, stool and colonic biopsies with amplicon-based 16S ribosomal RNA sequencing. This data will be correlated to CRC risk factors collected in a questionnaire covering lifestyle, diet and medical history as well as host genomic and transcriptomic profiling generated by targeted gene sequencing and microarray-based gene expression profiling. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human gut microbiome, Colorectal cancer, Colorectal adenoma, Gut bacteria, Metagenomics, Metatranscriptomics