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

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ClinicalTrials.gov Identifier: NCT02947607
Recruitment Status : Unknown
Verified May 2018 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : October 28, 2016
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
Janssen Pharmaceutica N.V., Belgium
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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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.

Condition or disease Intervention/treatment
Colorectal Adenoma and Carcinoma Procedure: Colon biopsies

Study Design
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Study Type : Observational
Estimated Enrollment : 1125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy control
Patients undergoing lower GI endoscopy without any colorectal adenoma or carcinoma.
 Procedure: Colon biopsies
Adenoma
Patients undergoing lower GI endoscopy with presence of colorectal adenoma detected.
 Procedure: Colon biopsies
Colorectal cancer
Patients diagnosed with colorectal cancer and referred to surgical carcinoma resection.
 Procedure: Colon biopsies


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Saliva Stool Tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947607


Contacts
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Contact: Sabine Tejpar, Prof. Dr. +32 16 345512 sabine.tejpar@uzleuven.be

Locations
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Belgium
Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Flemish Brabant, Belgium, 3000
Contact: Sara Verbandt, MSc    +16343490    sara.verbandt@kuleuven.be   
Contact: Vanessa Vangeel    +16342596    vanessa.vangeel@uzleuven.be   
Principal Investigator: Sabine Tejpar, MD PhD         
Netherlands
Academisch Medisch Centrum Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Maxime Bronzwaer, MD    +31 20 566 6464    m.e.bronzwaer@amc.uva.nl   
Contact: Aukje Munnik, MSc    +31 20 566 4109    a.munnik@amc.uva.nl   
Principal Investigator: Evelien Dekker, MD PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Janssen Pharmaceutica N.V., Belgium
KU Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02947607    
Other Study ID Numbers: s57084
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
Human gut microbiome
Colorectal cancer
Colorectal adenoma
 Gut bacteria
Metagenomics
Metatranscriptomics
Additional relevant MeSH terms:
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Carcinoma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms