NCT05636085|Not Yet RecruitingFDA Device
Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer and Advanced Adenoma
reconAAsense
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reconAAsense
Sponsor study identifier
observational
15,000
0 countries
N/A
Study Start
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study is to determine how the Mainz Biomed Colorectal Cancer Screening Test works when used in people aged ≥45 years of age and at an average risk of developing colorectal cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2022
Actual (reported)December 5, 2022
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Sensitivity Colorectal Cancer
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer
18 to 24 months
Sensitivity Advanced Adenoma
Sensitivity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Adenoma
18 to 24 months
Specificity
Specificity of the Mainz Biomed Colorectal Cancer Screening Test for Advanced Neoplasia
18 to 24 months
Positive predictive value and negative predictive value
18 to 24 months
Subjects ≥45 years of age and at average risk of colorectal cancer.
There is no intervention.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects that have been advised to have or are scheduled for a screening colonoscopy.
Stool samples
Danielle Kim Turgeon, MD
University of Michigan
First Submitted
November 23, 2022
First Posted
December 5, 2022
Study Start
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2027
EstimatedEvaluation of a New Blood-based Test to Detect Colorectal Cancer and Its Precursors
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 5, 2025
Record last verified: 2025-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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