Colorectal Cancer (Diagnosis)NCT07069556
ColoSense Post-Approval Study
An observational study of Colorectal Cancer (Diagnosis), run by Geneoscopy, Inc. at 1 site in United States.
Trial summary
The post-approval study (PAS) described here will supplement existing data generated in the CRC-PREVENT clinical trial. The primary outcomes of this supplemental study will include: clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV) of ColoSense. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (Diagnosis)
- What is being tested?
- ColoSense
- Type of treatment
- Medical device
- How many people
- 12,500 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2025to 1 Sep 2030
- 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: Subjects aged 45 years or older, who are at typical average-risk of developing colorectal neoplasms and are considered enrolled after understanding and consenting to ICF. Additional subjects outside the intended us population can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis.
Who may be able to join
- Subject is male or female, ≥45 years of age (subjects aged 18-45 can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis)
- Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form
- Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure
- Subject is able and willing to undergo a colonoscopy after providing a stool sample
Who cannot join
- Subject had any precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size
- Subject has a history or diagnosis of colorectal cancer
- Subject has a history of aerodigestive tract cancer
- Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals:
- Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
- FIT-DNA test within the previous 36 months
Show all 17Show fewer
- Subject has had a colonoscopy in the previous nine (9) years.
- Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
- Indication for colonoscopy was due to overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding)
- Subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
- Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP)
- Hereditary non-polyposis colorectal cancer syndrome (also referred to as "HNPCC" of "Lynch Syndrome")
- Other hereditary cancer syndromes including but are not limited to:
- Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Gardner's Syndrome
- Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis
- Cronkhite-Canada Syndrome, Neurofibromatosis and Familial Hyperplastic Polyposis
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
Decentralized Study
St Louis, Missouri, 63146
Erica K Barnell, MD PhD, 314-887-7777, contact@geneoscopy.com
About this study
Official title: ColoSense Post Approval Study
The post-approval study (PAS) described here will supplement existing data generated in the CRC-PREVENT clinical trial. The primary outcomes of this supplemental study will include: clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV) of ColoSense.
- Conditions
- Colorectal Cancer (Diagnosis)
- Being tested
- ColoSense
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColoSenseDevice
multi-target stool RNA test
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC Sensitivity
ColoSense sensitivity for subjects with colorectal cancer (CRC), which is the percentage of individuals with a diagnosis of CRC that were detected as positive by the ColoSense test.
Measured: Through study completion, an average of 5 years.
AA Sensitivity
ColoSense sensitivity for subjects with advanced adenomas (AA), which is the percentage of individuals with a diagnosis of AA that were detected as positive by the ColoSense test.
Measured: Through study completion, an average of 5 years.
SPL Sensitivity
ColoSense sensitivity for subjects with serrated precancerous lesions (SPL), which is the percentage of individuals with a diagnosis of SPL that were detected as positive by the ColoSense test.
Measured: Through study completion, an average of 5 years.
NEG Specificity
ColoSense specificity for subjects with negative findings, which is the percentage of individuals with a diagnosis of negative findings that were detected as negative by the ColoSense test.
Measured: Through study completion, an average of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start5 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (Diagnosis)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geneoscopy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069556
- Sponsor's protocol ID
- CT-PRT-0004
- Status last verified
- Nov 2025
- First submitted
- 27 Jun 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ColoSense Post Approval Study
- ClinicalTrials.gov ID
- NCT07069556
- Acronym / sponsor ID
- CT-PRT-0004
- Conditions
- Colorectal Cancer (Diagnosis)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,500 participants (estimated)
- Lead sponsor
- Geneoscopy, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 16 Jul 2025 (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.
The post-approval study (PAS) described here will supplement existing data generated in the CRC-PREVENT clinical trial. The primary outcomes of this supplemental study will include: clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV) of ColoSense.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 45 years or older, who are at typical average-risk of developing colorectal neoplasms and are considered enrolled after understanding and consenting to ICF. Additional subjects outside the intended us population can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis.
Key inclusion criteria (4 listed)
- Subject is male or female, ≥45 years of age (subjects aged 18-45 can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis)
- Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form
- Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure
- Subject is able and willing to undergo a colonoscopy after providing a stool sample
Key exclusion criteria (17 listed)
- Subject had any precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size
- Subject has a history or diagnosis of colorectal cancer
- Subject has a history of aerodigestive tract cancer
- Subject has had a positive non-invasive screening diagnostic within the associated recommended intervals:
- Subject has had a colonoscopy in the previous nine (9) years.
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 |
|---|---|---|
| ColoSensemulti-target stool RNA test | Device | – |
Primary outcome
CRC Sensitivity
Time frame: Through study completion, an average of 5 years.
ColoSense sensitivity for subjects with colorectal cancer (CRC), which is the percentage of individuals with a diagnosis of CRC that were detected as positive by the ColoSense test.
AA Sensitivity
Time frame: Through study completion, an average of 5 years.
ColoSense sensitivity for subjects with advanced adenomas (AA), which is the percentage of individuals with a diagnosis of AA that were detected as positive by the ColoSense test.
SPL Sensitivity
Time frame: Through study completion, an average of 5 years.
ColoSense sensitivity for subjects with serrated precancerous lesions (SPL), which is the percentage of individuals with a diagnosis of SPL that were detected as positive by the ColoSense test.
NEG Specificity
Time frame: Through study completion, an average of 5 years.
ColoSense specificity for subjects with negative findings, which is the percentage of individuals with a diagnosis of negative findings that were detected as negative by the ColoSense test.
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 21 Nov 2025.
- Individual participant dataSharing planned: No
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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 Cancer (Diagnosis), run by Geneoscopy, Inc. 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 4 inclusion and 17 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 21 Nov 2025. 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 Erica K Barnell, MD PhD (314-887-7777, contact@geneoscopy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRC Sensitivity (time frame: Through study completion, an average of 5 years.). The study lists 4 primary outcomes in all. 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 21 Nov 2025.