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

Colorectal Cancer Clinical Trial

— PREVENT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04693546
• Other study ID #: PM-2020-001
• Status: Not yet recruiting
• Start date: June 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2020
• Source: Metabiomics Corp
• Contact: Keri Donaldson, MD
• Phone: (717) 725-6925
• Email: kDonaldson[@]solvdhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12000
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Metabiomics Corp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity for the LifeKit Prevent Colorectal Neoplasia Test for adenoma, including advanced adenoma		Through study completion, an average of 180 days
Secondary	Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer		Through study completion, an average of 180 days
Secondary	Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for advanced adenoma		Through study completion, an average of 180 days
Secondary	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
Secondary	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