Characterization of human and microbial genetic components in normal colon tissue, colorectal adenomas, saliva and fecal samples

Characterization of human and microbial genetic components in normal colon tissue, colorectal adenomas, saliva and fecal samples - nvt

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43246

Enrollment

600

Registered

2016-10-20

Start date

2016-12-12

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: * 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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.-	—

Measure

Time frame

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.-

—

Countries

Netherlands

Outcome results