Colorectal PolypsNCT07786818
Metatranscriptomic Markers of Colonic Neoplasia
An observational study of Colorectal Polyps, run by Viome at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2025to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Individuals under 18 years of age
- Patients with a stoma
- Personal history of colorectal cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Viome Life Sciences
Bothell, Washington, 98011
Momchilo Vuyisich, PhD, 855-958-4663, studies@viome.com
About this study
Official title: 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.
- Conditions
- Colorectal Polyps
- Being tested
- This is an observational study that has no interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study that has no interventionsOther
This is an observational study that has no interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start20 Dec 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by ViomeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786818
- Sponsor's protocol ID
- V314
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metatranscriptomic Markers As A Predictor of Colonic Neoplasia at the Time of Colonoscopy
- ClinicalTrials.gov ID
- NCT07786818
- Acronym / sponsor ID
- V314
- Conditions
- Colorectal Polyps
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals under 18 years of age
- Patients with a stoma
- Personal history of colorectal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational study that has no interventionsThis is an observational study that has no interventions | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyps, run by Viome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Momchilo Vuyisich, PhD (855-958-4663, studies@viome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.