ClinicalTrials.gg
RecruitingNCT07786818Updated Aug 26, 2026

Metatranscriptomic Markers of Colonic Neoplasia

An observational study in Colorectal Polyps, sponsored by Viome. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Viome · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Colorectal Polyps

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03

In context

Polyps

312 studies on the registry are indexed under Polyps; 60 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 209 across 101 observational studies indexed under Polyps.

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Lead sponsor

Viome is the lead sponsor of 25 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherThis is an observational study that has no interventions

    This is an observational study that has no interventions

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What researchers measure

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.

    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.

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07786818
Lead sponsor
Viome
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Dec 20, 2025
Primary completion
Jan 30, 2027 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Momchilo Vuyisich, PhD
Contact
studies@viome.com
855-958-4663

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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