PCA3 Reference Set Application: Samantha Maragh NIST
- Abbreviated Name
- PCA3 Ref Set App: Maragh (2016)
- Lead Investigator
- Maragh, Samantha — National Institute of Standards and Technology
- Coordinating Investigator
- No coordinating investigator
- Involved Investigators
Abstact
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Aims
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Analytic Method
In order to account for variability between previous and the currently requested blinded sample set, NIST will require a training set of urine samples in addition to a blinded set of test samples. A training set of urine from age matched men with and without prostate cancer (5 cancers and 5 non-cancers) will represent 10% of the requested blinded test set and allow for assay performance confirmation prior to analysis of the blinded test set. A cohort of 50 cases and 50 controls is being requested where all samples are urine from men with elevated PSA and cases are men with prostate cancer while controls are age matched men without prostate cancer. This cohort size was determined by a power calculation with the parameters of Type I error of 0.05 and Power of 0.95 while also taking into account: the previous mtDNA biomarkers’ performances of 64.3% sensitivity and 86.7% specificity and 64.3% sensitivity and 100% specificity, the variability in sensitivity and specificity measurements, the possibility of sample exclusion from biomarker evaluation due to insufficient DNA quantity or quality.
Outcome
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Publications
Biomarkers
Data Collections
- No data collections available at this time for this protocol.
Team Project
- Finish Date
- Jul 26 2022
- Protocol ID
- 419
- Protocol Type
- Reference Set
- Field of Research
- Genomics
- Collaborative Group
- Prostate and Urologic Cancers Research Group
- Cancer Types
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- Malignant neoplasm of prostate