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Screening of colonic adenoma, serum, saliva and fecal samples to isolate and characterize Fusobacterium nucleatum and to characterize immunological infiltrates

Completed
Conditions
Colonic polyps
Microbiome
10017990
Registration Number
NL-OMON42783
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Known colorectal adenoma with a diameter greater than 1 cm
- If there are more adenomas greater than 1 cm found during colonoscopy the largest adenoma will be included in the study.
- Scheduled for colonoscopy for endoscopic treatment of the lesion at a dedicated colonoscopy program for large colorectal adenomas in the AMC;
- Signed the informed consent form
- Scheduled for colonoscopy for endoscopic treatment of the lesion at a dedicated colonoscopy program for large colorectal adenomas in the AMC;
- Signed the informed consent form
- Age greater than or equal to 18 years

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from participation in this study:
- Known to have a genetic polyposis syndrome (Familial Adenomatous Polyposis (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC)).
- Known or suspicion of inflammatory bowel disease.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The prevalence and abundance of F. nucleatum in biopsies from large adenomas,<br /><br>biopsies from healthy colorectal tissue and matching stool and saliva samples. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- The prevalence and abundance of microbes other than F. nucleatum in biopsies<br /><br>from large adenomas, biopsies from healthy colorectal tissue and matching stool<br /><br>and saliva samples.<br /><br>- The microbial gene expression including known or potential microbial<br /><br>virulence factors in the aforementioned tissues.<br /><br>- Characterization of immune cell subsets infiltrating adenoma samples<br /><br>- Characterisation of immunological infiltrates in adenoma samples and PBMC<br /><br>- Number of biopsies needed to obtain sufficient material to perform extensive<br /><br>flowcytometry to identify the different T cell and myeloid cell populations<br /><br>- Reactivity of different T cell and myeloid cell populations against adenoma<br /><br>and bacterial antigens</p><br>
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