An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now

Study Overview
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Brief Summary
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The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.

Detailed Description
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Subjects aged 45-49 at average risk for development of CRC will be enrolled. Subjects will complete the mt-sDNA screening test (Cologuard) followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test (Cologuard) will not be provided to investigators for clinical management of study subjects. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathological review of tissue (if applicable) will remain blinded to the results of the mt-sDNA screening test (Cologuard) result.

Official Title
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An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: mt-sDNA screening test
* Procedure: Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet the following criteria to be eligible for the study: Subject is at average risk for development of CRC. Subject is able and willing to undergo a screening colonoscopy. Subject is ≥ 45 and ≤ 49 years of age at the time of enrollment. Subject is willing and able to sign informed consent. Subject is able and willing to provide stool sample(s) according to written instructions provided. Exclusion Criteria: Subject has a history of CRC or adenoma. Subject has ≥2 first-degree relatives who have been diagnosed with CRC Subject has one first-degree relative with CRC diagnosed before the age of 60. Subject has any of the following: Overt rectal bleeding, e.g., hematochezia or melena within the previous 30 days (blood on toilet paper, after wiping, does not constitute rectal bleeding). Positive fecal occult blood test or FIT within the previous six (6) months. Subject has had a previous colonoscopy. Subject has undergone any double-contrast barium enema, virtual (CT-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years. Subject has a diagnosis or personal history of any of the following conditions, including: Familial adenomatous polyposis (also referred to as FAP, including attenuated FAP and Gardner's syndrome). Hereditary non-polyposis CRC syndrome (also referred to as HNPCC or Lynch Syndrome).Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis. Subject has a family history of: Familial adenomatous polyposis (also referred to as FAP), Hereditary non-polyposis CRC syndrome (also referred to as HNPCC or Lynch Syndrome). Subjects with Cronkhite-Canada Syndrome. Subject has a diagnosis of inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease. Subject has a history of aerodigestive tract cancer. Subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease. Subject has any condition that in the opinion of the investigator should preclude participation in the study.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject aged 45-49 with Average CRC Risk<br>Subject aged 45-49 with average risk for development of CRC. | Diagnostic Test: mt-sDNA screening test<br>* Stool samples will be collected by the subject for the mt-sDNA screening test.<br>* Other names: Cologuard;Procedure: Colonoscopy<br>* Subjects will undergo a screening colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49 | An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Specificity =100*(multi-target stool DNA test negative/negative colonoscopy) | Through study completion, an average of 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Sample Collection, Stool DNA