Metatranscriptomic Markers of Colonic Neoplasia

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.

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Key information

Conditions

Colorectal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Viome Life Sciences

Bothell, Washington, 98011, United States

Location status: Recruiting

Location contact

Momchilo Vuyisich, PhD

CONTACT

[email protected]

855-958-4663

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

This is an observational study that has no interventions

Other

This is an observational study that has no interventions

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Momchilo Vuyisich, PhD

CONTACT

[email protected]

855-958-4663

Sponsors and collaborators

Lead sponsor

Viome

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Aug 26, 2026
Registry last updated: Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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