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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04693546
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Metabiomics Corp

Tracking Information
First Submitted Date December 28, 2020
First Posted Date January 5, 2021
Last Update Posted Date January 5, 2021
Estimated Study Start Date June 2021
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 30, 2020)		 Sensitivity and specificity for the LifeKit Prevent Colorectal Neoplasia Test for adenoma, including advanced adenoma [ Time Frame: Through study completion, an average of 180 days ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 30, 2020)
  • Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer [ Time Frame: Through study completion, an average of 180 days ]
  • Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for advanced adenoma [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through study completion, an average of 180 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Colorectal Cancer
  • Colorectal Adenoma
Intervention
  • Diagnostic Test: LifeKit Prevent Colorectal Neoplasia Test
    Procedure: Colonoscopy
  • Diagnostic Test: FIT Test
    Procedure: Colonoscopy
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: December 30, 2020)		 12000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Keri Donaldson, MD (717) 725-6925 kDonaldson@solvdhealth.com
Contact: Gregory J Kuehn (619) 614-0891 gjkuehn@metabiomics.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04693546
Other Study ID Numbers PM-2020-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Current Responsible Party Metabiomics Corp
Original Responsible Party Same as current
Current Study Sponsor Metabiomics Corp
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Metabiomics Corp
Verification Date December 2020