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

Colorectal Adenoma and Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947607
• Other study ID #: s57084
• Status: Completed
• Start date: July 2016
• Est. completion date: April 2019

Study information

• Verified date: May 2018
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 799
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Carcinoma
• Colorectal Adenoma and Carcinoma

Intervention

Procedure:
• Colon biopsies

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven	Flemish Brabant
Netherlands	Academisch Medisch Centrum	Amsterdam

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Janssen Pharmaceutica N.V., Belgium, KU Leuven

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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