Metatranscriptomic Markers of Colonic Neoplasia

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07786818

Enrollment

1000

Registered

2026-08-26

Start date

2025-12-20

Completion date

2027-01-30

Last updated

2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Polyps

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.

Interventions

OTHERThis is an observational study that has no interventions

This is an observational study that has no interventions

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance	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.

Countries

United States

Contacts

CONTACTMomchilo Vuyisich, PhD

studies@viome.com855-958-4663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026