Recruiting

Colorectal Polyp Detection

Sponsor:

Viome

Code:

NCT07786818

Conditions

Colorectal Polyps

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

This is an observational study that has no interventions

Study Details

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

Study ID

NCT07786818

Start date

Dec 20, 2025

Status verified date

Aug, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

This is an observational study that has no interventions

This is an observational study that has no interventions

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Momchilo Vuyisich, PhD

855-958-4663studies@viome.com

Locations

Viome Life Sciences

Recruiting

Bothell, Washington, United States, 98011

Contacts

Momchilo Vuyisich, PhD

855-958-4663studies@viome.com

More Information

Sponsor

Viome

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Viome on 2026-08-26.