Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening (PREVENT)
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ClinicalTrials.gov Identifier: NCT04693546 |
Recruitment Status : Unknown
Verified December 2020 by Metabiomics Corp.
Recruitment status was: Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
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Condition or disease | Intervention/treatment |
---|---|
Colorectal Cancer Colorectal Adenoma | Diagnostic Test: LifeKit Prevent Colorectal Neoplasia Test Diagnostic Test: FIT Test |
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 |
- Diagnostic Test: LifeKit Prevent Colorectal Neoplasia Test
Procedure: Colonoscopy
- Diagnostic Test: FIT Test
Procedure: Colonoscopy
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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.
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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.
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
Contact: Keri Donaldson, MD | (717) 725-6925 | kDonaldson@solvdhealth.com | |
Contact: Gregory J Kuehn | (619) 614-0891 | gjkuehn@metabiomics.com |
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 |
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 |
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 |