Primary Objective: The primary objective is to study the potential role of F. nucleatum in the development of colorectal cancer by isolating F. nucleatum strains from large adenoma biopsies, healthy colorectal tissue and matching stool and saliva…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence and abundance of F. nucleatum in biopsies from large adenomas,
biopsies from healthy colorectal tissue and matching stool and saliva samples.
Secondary outcome
- 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
Background summary
Recently, a central role for bacteria in the development of colorectal cancer
(CRC) is being proposed, and it is hypothesized that these microbes may
integrate diet and host genetics in the etiology of the disease. Especially F.
nucleatum, but also other microbes may play an essential role in colonic
carcinogenesis. Little is known about virulence factors of F. nucleatum, i.e.
the genes and gene products that play an essential role in its pathogenicity,
which would allow one to focus upon a key therapeutic molecular target and
enable diagnostics
Study objective
Primary Objective:
The primary objective is to study the potential role of F. nucleatum in the
development of colorectal cancer by isolating F. nucleatum strains from large
adenoma biopsies, healthy colorectal tissue and matching stool and saliva
samples for genetic characterization and to assess the tumorigenic potential of
these isolates.
Secondary Objective(s):
The second objectives are to establish nucleic acid extraction protocols from
biopsies and matching stool and saliva samples to allow comparison of the
microbiome in normal and diseased tissues, stool and saliva from individuals
with adenomas or CRC and characterization of microbial gene expression
including microbial virulence factors expressed in adenoma and CRC tissues. We
also aim to allow characterization of immune cell subsets infiltrating adenoma
tissue and PBMC.
Study design
Cross-sectional study with the collection of large adenoma biopsies, healthy
colorectal tissue and matching stool and saliva samples.
Study burden and risks
Prior to the colonoscopy two saliva samples and two fecal samples will be
obtained from the participating patients. No additional risks are associated
with the retrieval of these samples. The retrieval of serum is associated with
a minimal bleeding risk and a minimal risk of the formation of hematoma.
During the colonoscopy three additional biopsies will be taken from
healthy colorectal tissue and the risks associated with these biopsies are a
minimal bleeding risk.
The additional biopsies of the adenoma after the polypectomy will be taken at
the luminal side of the removed adenoma, whereby the histopathology diagnosis
of the polyp will not be influenced.
Archimedesweg 6
Leiden 2333 CN
NL
Archimedesweg 6
Leiden 2333 CN
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54689.018.15 |