The primary objective of this study is the simultaneous characterization of human and microbiota genomic and transcriptomic components in healthy and adenoma mucosal samples as well as stool and saliva. In addition, microbiome shifts from normal…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is the composition and abundance of microbiota
genomic and transcriptomic components in healthy and adenoma mucosal samples as
well as stool and saliva.
Secondary outcome
The following secondary study parameters are designed to further compare the
microbiome in normal and diseased tissues and matching stool and saliva and
determine differences from patients with and without adenomas.
- Shifts in microbiome composition and abundance from normal mucosal to adenoma
and its correlation with luminal and oral bacteria.
- Characterization of mechanisms through which microbiota cause or contribute
to oncogenesis.
- Characterization of molecular sub-classification of polyps and its comparison
to colon tumors.
- Identification of the presences of inflammation in the adenomas and its
potential link with microbiome composition and abundance.
- Differences in transcriptomics and metatranstcriptomics (gene expression) of
normal mucosa and adenomatous tissue.
- Characterize differences in composition and abundance of oral microbiota in
patients with and without adenomas by taking saliva samples of three different
oral mucosa locations.-
Background summary
Due to human the complexity of human gut microbiota and its implication in
other gastrointestinal disorders, a potential pathogenic role for bacteria in
CRC has been proposed for a long time, and more recently associations between
bacteria and premalignant polyp development have also been found. Despite the
advances made in this emerging field, most of the research conducted until now
has studied human intestinal microflora from fecal samples. Interestingly,
little is known about the potential correlation of gut microbiota with specific
polyp and tumor host molecular features.
Study objective
The primary objective of this study is the simultaneous characterization of
human and microbiota genomic and transcriptomic components in healthy and
adenoma mucosal samples as well as stool and saliva. In addition, microbiome
shifts from normal mucosa to polyp to adenocarcinoma and its correlation with
luminal and oral bacteria, mechanisms through which microbiota cause or
contribute to oncogenesis, molecular sub-classification of polyps, inflammation
in polyps and its potential link with the microbiome will be further
investigated. This study also aims to develop tools to analyse complex
microbiome structures.
Study design
Cross-sectional study consisting of prospective tissue sampling of healthy
colorectal biopsies, biopsies from adenomatous tissue and matched saliva and
stool samples.
Study burden and risks
Prior to the colonoscopy three saliva samples and two fecal samples will be
obtained from the participating patients. No additional risks are associated
with the retrieval of these samples. During the colonoscopy additional biopsies
will be taken from healthy colorectal tissue, and after polypectomy additional
biopsies will be taken form the luminal side of the resected adenoma, and the
risks associated with these biopsies are a minimal bleeding risk.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
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:
* Scheduled for a regular colonoscopy
* Aged 18 years or above
* Colonoscopy schedualed for one of the following indications:
o Positive FOBT (Fecal Occult Blood Test) outside of the national screening program for colorectal cancer
o Follow up after polypectomy or colorectal cancner
o Rectal blood loss or anemia
o Abdominal pain
o Familial history of colon cancer or adenoma
o Abnormal radiologic imaging of the colonsuch as barium enema or CT colonography
o Change in bowel habits
* Singed informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
* Previous surgical bowel resection, except from appendectomy
* 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 | NL57805.018.16 |