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ColoSense Post-Approval Study

ColoSense Post Approval Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks how accurate the ColoSense test is. It is mainly for adults age 45 and older who can give a stool sample and then have a colonoscopy, an exam of the colon.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 45 or older. Adults ages 18–45 may also join, but their results will not count in the main study analysis.
  • You can understand the study, agree to take part, and give permission to share your relevant medical records.
  • You can and will give a stool sample within 120 days before your colonoscopy.
  • You can and will have a colonoscopy after giving the stool sample.

Who can't join

  • Your most recent colonoscopy found changes that could turn into cancer. Benign or hyperplastic polyps, types of noncancerous growths, do not count.
  • You have or have had cancer of the colon or rectum, or cancer in the passages used for breathing or moving food.
  • You had a positive stool blood test (FOBT or FIT) in the past 12 months, or a positive FIT-DNA stool test in the past 36 months.
  • You had a colonoscopy in the past 9 years.
  • You had surgery to remove part of your colon or rectum, unless it was for sigmoid diverticular disease—a problem with small pouches in the lower colon.
  • Your colonoscopy is being done because of visible rectal bleeding in the past 30 days, such as bloody or black stools. Blood only on toilet paper after wiping does not count.
  • You have or have had inflammatory bowel disease, including ulcerative colitis or Crohn’s disease, which cause swelling in the gut.
  • You have or have had a listed high-risk condition: FAP, Lynch syndrome, Peutz-Jeghers, MYH-associated polyposis, Gardner’s, Turcot’s (Crail’s), Cowden’s, juvenile polyposis, Cronkhite-Canada, neurofibromatosis, familial hyperplastic polyposis, or another inherited cancer syndrome.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (1)

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