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

Completed

• Conditions: Colorectal Adenoma and Carcinoma
• Interventions: Procedure: Colon biopsies

• Registration Number: NCT02947607
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-28
• Status Verified: 2018-05
• Primary Completion: 2018-12
• Study Completion: 2019-04
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 799

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy control	Colon biopsies	Patients undergoing lower GI endoscopy without any colorectal adenoma or carcinoma.
Adenoma	Colon biopsies	Patients undergoing lower GI endoscopy with presence of colorectal adenoma detected.
Colorectal cancer	Colon biopsies	Patients diagnosed with colorectal cancer and referred to surgical carcinoma resection.

Primary Outcome Measures

Name	Time	Method
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.	2 years	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.

Trial Locations

Locations (2)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Flemish Brabant, Belgium