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ColoSense Post-Approval Study for Colorectal Cancer Diagnosis

This study is looking at a device called ColoSense, which is a multi-target stool RNA test. It's designed to help diagnose colorectal cancer. Researchers want to see how well ColoSense can find colorectal cancer (CRC Sensitivity), advanced adenomas (AA Sensitivity), and significant polyps (SPL Sensitivity). They will measure this over an average of 5 years. You can join if you are male or female and at least 45 years old. The study aims to enroll 12,500 people. The current status of the study is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving specific treatments. It plans to include 12,500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants to measure outcomes for an average of 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07069556

ColoSense Post-Approval Study

Recruiting
Not specifiedAges 18+Observational
Geneoscopy, Inc.
~12,500 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:ColoSense

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CRC Sensitivity
Measured over Through study completion, an average of 5 years.
+3 more outcomes measured

Conditions

Colorectal Cancer (Diagnosis)

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Missouri1

Who to contact

Erica K Barnell, MD PhD
[email protected]
314-887-7777
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
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

What this trial measures

  • CRC SensitivityThrough 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 SensitivityThrough 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 SensitivityThrough 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 SpecificityThrough 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.