- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02947607
Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma
January 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
799
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Flemish Brabant
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Leuven, Flemish Brabant, Belgium, 3000
- Universitaire Ziekenhuizen Leuven
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Amsterdam, Netherlands, 1105 AZ
- Academisch Medisch Centrum
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Healthy control
Patients undergoing lower GI endoscopy without any colorectal adenoma or carcinoma.
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Adenoma
Patients undergoing lower GI endoscopy with presence of colorectal adenoma detected.
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Colorectal cancer
Patients diagnosed with colorectal cancer and referred to surgical carcinoma resection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
October 13, 2016
First Submitted That Met QC Criteria
October 25, 2016
First Posted (Estimate)
October 28, 2016
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- s57084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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