Prevention of Colorectal Cancer Through Multiomics Blood Testing (PREEMPT CRC)
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04369053 |
Recruitment Status :
Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : February 28, 2024
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Sponsor:
Freenome Holdings Inc.
Information provided by (Responsible Party):
Freenome Holdings Inc.
Tracking Information | ||||||||||
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First Submitted Date | April 27, 2020 | |||||||||
First Posted Date | April 30, 2020 | |||||||||
Last Update Posted Date | February 28, 2024 | |||||||||
Actual Study Start Date | May 20, 2020 | |||||||||
Estimated Primary Completion Date | May 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures | Not Provided | |||||||||
Original Secondary Outcome Measures | Not Provided | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title | Prevention of Colorectal Cancer Through Multiomics Blood Testing | |||||||||
Official Title | Prevention of Colorectal Cancer Through Multiomics Blood Testing | |||||||||
Brief Summary | The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy. | |||||||||
Detailed Description | Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy. | |||||||||
Study Type | Observational | |||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||||||||
Biospecimen | Retention: Samples With DNA Description: Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test.
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Sampling Method | Non-Probability Sample | |||||||||
Study Population | Participants aged between 45 and 85 who are eligible for CRC screening and scheduled for a standard-of-care screening colonoscopy. | |||||||||
Condition |
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Intervention | Diagnostic Test: Freenome test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. Participants will undergo blood collection and will then complete a standard-of-care screening colonoscopy.
Other Name: Single Group Assignment
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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. |
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Recruitment Information | ||||||||||
Recruitment Status | Active, not recruiting | |||||||||
Estimated Enrollment |
50000 | |||||||||
Original Estimated Enrollment |
14000 | |||||||||
Estimated Study Completion Date | May 30, 2024 | |||||||||
Estimated Primary Completion Date | May 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria | Key Inclusion Criteria
Key Exclusion Criteria
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Sex/Gender |
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Ages | 45 Years to 85 Years (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers | Yes | |||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries | United Arab Emirates, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number | NCT04369053 | |||||||||
Other Study ID Numbers | FRNM-004 | |||||||||
Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Freenome Holdings Inc. | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor | Freenome Holdings Inc. | |||||||||
Original Study Sponsor | Same as current | |||||||||
Collaborators | Not Provided | |||||||||
Investigators |
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PRS Account | Freenome Holdings Inc. | |||||||||
Verification Date | February 2024 |