Metatranscriptomic Markers of Colonic Neoplasia

NCT07786818 | Recruiting

• 1 other identifier: V314
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Polyps

Outcome Measures

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.

  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.

Interventions

This is an observational study that has no interventions OTHER

This is an observational study that has no interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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

You may not qualify if:

• Individuals under 18 years of age
• Patients with a stoma
• Personal history of colorectal cancer

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and stool samples

Central Study Contacts

Momchilo Vuyisich, PhD

CONTACT

855-958-4663; studies@viome.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 26, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

US (1)