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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

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.

Condition or disease Intervention/treatment
Colorectal Cancer Colorectal Adenoma Diagnostic Test: LifeKit Prevent Colorectal Neoplasia Test Diagnostic Test: FIT Test

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.

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Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for Colorectal Cancer Screening
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: LifeKit Prevent Colorectal Neoplasia Test
    Procedure: Colonoscopy
  • Diagnostic Test: FIT Test
    Procedure: Colonoscopy


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer [ Time Frame: Through study completion, an average of 180 days ]
  2. Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for advanced adenoma [ Time Frame: Through study completion, an average of 180 days ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693546


Contacts
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Contact: Keri Donaldson, MD (717) 725-6925 kDonaldson@solvdhealth.com
Contact: Gregory J Kuehn (619) 614-0891 gjkuehn@metabiomics.com

Sponsors and Collaborators
Metabiomics Corp
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Responsible Party: Metabiomics Corp
ClinicalTrials.gov Identifier: NCT04693546    
Other Study ID Numbers: PM-2020-001
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020

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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
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type