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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02947607

Enrollment

799

Registered

2016-10-28

Start date

2016-07-31

Completion date

2019-04-30

Last updated

2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenoma and Carcinoma

Keywords

Human gut microbiome, Colorectal cancer, Colorectal adenoma, Gut bacteria, Metagenomics, Metatranscriptomics

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.

Interventions

PROCEDUREColon biopsies

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026