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Recruiting NCT07069556

ColoSense Post-Approval Study

— Observational Colorectal Cancer (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ColoSense.
Who it may be relevant to
Registry conditions: Colorectal Cancer (Diagnosis). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

ColoSense Post Approval Study

Overview

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.

Interventions

  • Device ColoSense
    multi-target stool RNA test

Primary outcome measures

  • CRC Sensitivity [Time frame: Through study completion, an average of 5 years.]
  • AA Sensitivity [Time frame: Through study completion, an average of 5 years.]
  • SPL Sensitivity [Time frame: Through study completion, an average of 5 years.]
  • NEG Specificity [Time frame: Through study completion, an average of 5 years.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Decentralized Study — St Louis

Identifiers

NCT: NCT07069556 · CT-PRT-0004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗