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

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.

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Key information

Conditions

Colorectal Adenoma and Carcinoma Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaire Ziekenhuizen Leuven, Leuven, Flemish Brabant, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colon biopsies

Procedure

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

Janssen Pharmaceutica N.V., Belgium
KU Leuven

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2019
First posted: Oct 28, 2016
Registry last updated: Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed