Metatranscriptomic Markers of Colonic Neoplasia

August 24, 2026 updated by: Viome

Metatranscriptomic Markers As A Predictor of Colonic Neoplasia at the Time of Colonoscopy

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.

Study Overview

Status

Recruiting

Conditions

Colorectal Polyps

Intervention / Treatment

Other: This is an observational study that has no interventions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Momchilo Vuyisich, PhD
Phone Number: 855-958-4663
Email: studies@viome.com

Study Locations

United States
- Washington
  - Bothell, Washington, United States, 98011
    - Recruiting
    - Viome Life Sciences
    - Contact:
      
      Momchilo Vuyisich, PhD
      
      Phone Number: 855-958-4663
      
      Email: studies@viome.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance 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.	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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2025

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)