Clinical trial NCT02947607: Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma
Official title: Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Adenoma and Carcinoma
Keywords: Human gut microbiome
Colorectal cancer
Colorectal adenoma
Gut bacteria
Metagenomics
Metatranscriptomics
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceutica N.V., Belgium
name: KU Leuven
First posted: 2016-10-28
Enrollment: 799
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants are patients with CRC that will undergo surgical tumor resection or patients referred for lower GI endoscopy.

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
state: Flemish Brabant
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
Study officials:
References: