Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening

Study Overview
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Brief Summary
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The purpose of this study is to determine the sensitivity and specificity for LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer (CRC) and for adenoma, including advanced adenoma.

Detailed Description
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Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subjects will collect a stool sample that will be tested by the LifeKit Prevent Colorectal Neoplasia Test at a central laboratory and that will be tested using a commercially available FIT. After sample collection, subjects will undergo a screening colonoscopy per standard of care. Investigators will be blinded to the results of the LifeKit Prevent Colorectal Neoplasia Test during the study; the LifeKit Prevent Colorectal Neoplasia Test and FIT results will not be used for clinical management of subjects. Personnel performing the colonoscopy and reports from the colonoscopy and personnel performing the histopathological review of the tissue and/or any reports will remain blinded to the results of the LifeKit Prevent Colorectal Neoplasia Test results.

Official Title
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Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for Colorectal Cancer Screening

Conditions
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Colorectal Cancer, Colorectal Adenoma

Intervention / Treatment
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* Diagnostic Test: LifeKit Prevent Colorectal Neoplasia Test
* Diagnostic Test: FIT Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An individual must meet all of the criteria below to be eligible. Subject is ≥ 40 years of age at the time of enrollment. Subject presents for a screening colonoscopy per standard of care. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. Subject is able and willing to sign informed consent. Exclusion Criteria: An individual meeting any of the below criteria is ineligible. Subject has a history of CRC or advanced precancerous lesions. Subject has a diagnosis or medical history of any of the following conditions: 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, or Familial Hyperplastic Polyposis Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease. Subject has a diagnosis of Cronkhite-Canada Syndrome. Subject has had a positive Cologuard, fecal occult blood test or FIT within the previous 2 years. Subject has undergone a colonoscopy within the previous 9 years. Subject has had overt rectal bleeding within the previous 30 days. 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: 40 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

| Intervention/Treatment |
| --- |
|Diagnostic Test: LifeKit Prevent Colorectal Neoplasia Test|Procedure: Colonoscopy|
|Diagnostic Test: FIT Test|Procedure: Colonoscopy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity for the LifeKit Prevent Colorectal Neoplasia Test for adenoma, including advanced adenoma |  | Through study completion, an average of 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer |  | Through study completion, an average of 180 days | 
| Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for advanced adenoma |  | Through study completion, an average of 180 days | 
| Sensitivity of the LifeKit Prevent Colorectal Neoplasia Test is non-inferior to that of FIT for colorectal cancer |  | Through study completion, an average of 180 days | 
| Sensitivity of the LifeKit Prevent Colorectal Neoplasia Test is superior to that of FIT for advanced adenoma |  | Through study completion, an average of 180 days |