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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

799 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Colorectal Adenoma and Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy control

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

Colon biopsies

Intervention Type PROCEDURE

Adenoma

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

Colon biopsies

Intervention Type PROCEDURE

Colorectal cancer

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

Colon biopsies

Intervention Type PROCEDURE

Interventions

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Colon biopsies

Intervention Type PROCEDURE

Eligibility Criteria

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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.

* 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

CRC patients

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes