An observational study in Colorectal Polyps, sponsored by Viome. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Viome · Observational
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.
312 studies on the registry are indexed under Polyps; 60 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 209 across 101 observational studies indexed under Polyps.
Browse Polyps studies →Viome is the lead sponsor of 25 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
This is an observational study that has no interventions
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.
Plan to share: Undecided
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