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

January 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

799

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants are patients with CRC that will undergo surgical tumor resection or patients referred for lower GI endoscopy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

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.
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

May 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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