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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42783

Enrollment

200

Registered

2015-10-09

Start date

2016-01-05

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic polyps Microbiome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The prevalence and abundance of F. nucleatum in biopsies from large adenomas, biopsies from healthy colorectal tissue and matching stool and saliva samples.	—

Secondary

Measure	Time frame
- The prevalence and abundance of microbes other than F. nucleatum in biopsies from large adenomas, biopsies from healthy colorectal tissue and matching stool and saliva samples. - The microbial gene expression including known or potential microbial virulence factors in the aforementioned tissues. - Characterization of immune cell subsets infiltrating adenoma samples - Characterisation of immunological infiltrates in adenoma samples and PBMC - Number of biopsies needed to obtain sufficient material to perform extensive flowcytometry to identify the different T cell and myeloid cell populations - Reactivity of different T cell and myeloid cell populations against adenoma and bacterial antigens	—

Measure

Time frame

- The prevalence and abundance of microbes other than F. nucleatum in biopsies from large adenomas, biopsies from healthy colorectal tissue and matching stool and saliva samples. - The microbial gene expression including known or potential microbial virulence factors in the aforementioned tissues. - Characterization of immune cell subsets infiltrating adenoma samples - Characterisation of immunological infiltrates in adenoma samples and PBMC - Number of biopsies needed to obtain sufficient material to perform extensive flowcytometry to identify the different T cell and myeloid cell populations - Reactivity of different T cell and myeloid cell populations against adenoma and bacterial antigens

—

Countries

Netherlands

Outcome results