Metatranscriptomic Markers of Colonic Neoplasia
ConditionColorectal Polyps
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorViome
About this trial
This study is a collaboration between Viome Life Sciences and Scripps Research Institute to develop and validate a noninvasive molecular diagnostic test for the detection of colorectal polyps. Approximately 1,000 participants undergoing colonoscopy will provide saliva and stool samples prior to their procedure. Molecular features identified in these samples will be evaluated in relation to colonoscopy findings to develop a predictive model for colorectal polyp detection. The resulting model will then be evaluated in an independent validation dataset to assess its performance for identifying individuals with colorectal polyps.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female, aged 18 years or older
Undergoing colonoscopy with bowel preparation
Able to provide stool and saliva samples prior to colonoscopy
No stoma present
Disqualifiers
Individuals under 18 years of age
Patients with a stoma
Personal history of colorectal cancer
Trial population
* Male or female, aged 18 years or older * Undergoing colonoscopy with bowel preparation * Able to provide stool and saliva samples prior to colonoscopy * No stoma present * No known personal history of colorectal cancer
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
This is an observational study that has no interventions
Other interventionThis is an observational study that has no interventions
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Diagnostic performance
Performance of the molecular classifier for identifying participants with one or more colorectal polyps, using colonoscopy and pathology findings as the reference standard. Performance will be assessed in an independent validation dataset using sensitivity, specificity, area under the receiver operating characteristic curve, positive predictive value, and negative predictive value.
Time frame
Participants collect study samples between 4 weeks and 1 day prior to initiation of bowel preparation for colonoscopy. Colonoscopy findings and associated pathology results are subsequently collected electronically as part of the study. Source ClinicalTrials.gov