Colorectal CancerPREVENTNCT04693546
Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Metabiomics Corp at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma
- What is being tested?
- LifeKit Prevent Colorectal Neoplasia Test and FIT Test
- How many people
- 12,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Mar 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- An individual meeting any of the below criteria is ineligible.
- Subject has a history of CRC or advanced precancerous lesions.
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for Colorectal Cancer Screening
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.
Read the 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.
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Being tested
- LifeKit Prevent Colorectal Neoplasia Test, FIT Test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeKit Prevent Colorectal Neoplasia TestDiagnostic test
Procedure: Colonoscopy
FIT TestDiagnostic test
Procedure: Colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for the LifeKit Prevent Colorectal Neoplasia Test for adenoma, including advanced adenoma
Measured: Through study completion, an average of 180 days
Secondary outcomes (4)
Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer
Measured: Through study completion, an average of 180 days
Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for advanced adenoma
Measured: 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
Measured: 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
Measured: Through study completion, an average of 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Mar 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Why it stopped: fundraising
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metabiomics Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693546
- Sponsor's protocol ID
- PM-2020-001
- Acronym
- PREVENT
- Status last verified
- Sep 2025
- First submitted
- 28 Dec 2020
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT04693546
- Acronym / sponsor ID
- PREVENT / PM-2020-001
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: fundraising
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Metabiomics CorpIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- An individual meeting any of the below criteria is ineligible.
- Subject has a history of CRC or advanced precancerous lesions.
- Subject has a diagnosis or medical history of any of the following conditions:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeKit Prevent Colorectal Neoplasia TestProcedure: Colonoscopy | Diagnostic test | – |
| FIT TestProcedure: Colonoscopy | Diagnostic test | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Metabiomics Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.