We hypothesize that VOCs hold potential as a non-invasive screening tool for detection of colorectal neoplastic lesions in Lynch syndrome. Faecal composition of microbiota as well as amino acids and proteins might be other potential non-invasive…
ID
Source
Brief title
Health condition
Lynch syndrome, colorectal neoplasia (colorectal cancer and polyps/adenomas)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy (in terms of sensitivity, specificity and area under the curve) of an electronic nose by means of faecal VOC analysis in detecting colorectal neoplasia (CRC and its precursors) in patients with Lynch syndrome.
Secondary outcome
* The accuracy (in terms of sensitivity, specificity and area under the curve) of an electronic nose by means of urinal VOC analysis in detecting colorectal neoplasia (CRC and its precursors) in patients with Lynch syndrome. * The accuracy (in terms of sensitivity, specificity and area under the curve) of an electronic nose by means of faecal VOC analysis in follow-up of colorectal neoplasia in patients with Lynch syndrome. * Analysis of the intestinal microbiome in Lynch syndrome patients * The accuracy (in terms of sensitivity, specificity and area under the curve) of faecal amino acid, microbial and protein composition as markers for detection of colorectal neoplasia in patients with Lynch syndrome
Background summary
National multicentre prospective trial evaluating the use of faecal/urinal VOCs, faecal microbiota, faecal amino acids and faecal protein profiles as markers for detection of colorectal neoplasia in patients with Lynch syndrome. In addition, we will explore the microbial signature in these patients. Patients will fill in questionnaires and stool and urine samples will be collected. VOCs from patients with CRC and/or adenoma(s) detected at surveillance colonoscopy (performed 2-yearly as part of routine care), will be compared to subjects without CRC and adenomas by using an electronic nose (GC-IMS). Faecal microbial composition, amino acids and protein profiles will be analysed using 16 S rRNA amplicon sequencing or (shotgun) metagenomic analysis, High Performance Liquid Chromatography (HPLC) and LC-MS/MS, respectively.
Study objective
We hypothesize that VOCs hold potential as a non-invasive screening tool for detection of colorectal neoplastic lesions in Lynch syndrome. Faecal composition of microbiota as well as amino acids and proteins might be other potential non-invasive biomarkers for CRC and adenoma. Potentially, timing of endoscopy could be guided by non-invasive biomarkers in future. Lastly, patients with Lynch syndrome may harbour an aberrant or different colonic microbiome, that might contribute to the elevated risk of developing colorectal cancer.
Study design
Patients will be asked to collect stool samples at inclusion and then 6-monthly during a two-year period (5 samples). This will include a sample 1 – 4 weeks prior to colonoscopy and three months after colonoscopy. Some patients will also collect urine samples at the same set times. Additionally, Patients will complete a questionnaire on the day of sample collection. Biannual colonoscopy will be performed as part of the routine surveillance program.
Intervention
-
Inclusion criteria
* proven germline mutation in one of the mismatch-repair genes * planned colonoscopy during study period * ≥ 18 years of age * capable of giving informed consent * speak and understand the Dutch language
Exclusion criteria
* No informed consent * Incomplete endoscopic assessment due to various reasons (e.g. inadequate bowel cleansing, pain), unless obstructive CRC is found * Diagnosis of other gastrointestinal diseases besides Lynch syndrome
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8749 |
| Other | METC VUmc : 2020.317 |