Clinical trial NCT04693546: Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening
Official title: Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for Colorectal Cancer Screening
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Colorectal Adenoma
Lead sponsor: Metabiomics Corp
Sponsor class: INDUSTRY
First posted: 2021-01-05
Enrollment: 12000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 40 years of age and older who are eligible for colorectal cancer screening and scheduled for a screening colonoscopy per standard of care. Approximately 12,000 subjects will be targeted for enrollment.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

An individual must meet all of the criteria below to be eligible.

1. Subject is ≥ 40 years of age at the time of enrollment.
2. Subject presents for a screening colonoscopy per standard of care.
3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
4. Subject is able and willing to sign informed consent.

Exclusion Criteria:

An individual meeting any of the below criteria is ineligible.

1. Subject has a history of CRC or advanced precancerous lesions.
2. 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
3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease.
4. Subject has a diagnosis of Cronkhite-Canada Syndrome.
5. Subject has had a positive Cologuard, fecal occult blood test or FIT within the previous 2 years.
6. Subject has undergone a colonoscopy within the previous 9 years.
7. Subject has had overt rectal bleeding within the previous 30 days.
8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Primary outcomes:
measure: Sensitivity and specificity for the LifeKit Prevent Colorectal Neoplasia Test for adenoma, including advanced adenoma
timeFrame: Through study completion, an average of 180 days
Secondary outcomes:
measure: Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer
timeFrame: Through study completion, an average of 180 days
measure: Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for advanced adenoma
timeFrame: Through study completion, an average of 180 days
measure: Sensitivity of the LifeKit Prevent Colorectal Neoplasia Test is non-inferior to that of FIT for colorectal cancer
timeFrame: Through study completion, an average of 180 days
measure: Sensitivity of the LifeKit Prevent Colorectal Neoplasia Test is superior to that of FIT for advanced adenoma
timeFrame: Through study completion, an average of 180 days
Other outcomes:
Locations:
Study officials:
References: