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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Colorectal Adenoma and Carcinoma

Treatments: Procedure: Colon biopsies

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02947607

s57084

Details and patient eligibility

About

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.

Enrollment: 799 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

• Previous diagnosis of an inflammatory bowel disease
• Previous diagnosis of intestinal polyposis syndrome

Trial design

799 participants in 3 patient groups

Healthy control

Description:

Patients undergoing lower GI endoscopy without any colorectal adenoma or carcinoma.

Treatment:

Procedure: Colon biopsies

Adenoma

Description:

Patients undergoing lower GI endoscopy with presence of colorectal adenoma detected.

Treatment:

Procedure: Colon biopsies

Colorectal cancer

Description:

Patients diagnosed with colorectal cancer and referred to surgical carcinoma resection.

Treatment:

Procedure: Colon biopsies