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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-07202 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00117711 | Other Identifier | University of Michigan Rogel Cancer Center | |
| P50CA186786 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
This study evaluates urinary biomarkers and PSA to help determine the best approach to early detection of prostate cancer in patients with an elevated familial risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo urine and blood sample collection, provide family history of cancer and have their medical records reviewed throughout the study. Patients also undergo a digital rectal examination, complete a questionnaire and receive results of the PSA blood test and urine biomarker test. Patients with an elevated PSA level above 2.0 ng/ml (age 40-49) or 2.5 ng/ml (age 50-70) or abnormal urine test will be referred for an ultrasound-guided biopsy of the prostate gland. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Predictors of any HG PCa | Descriptive statistics, parametric and non-parametric statistical tests will be used to summarize the clinical variables. Will estimate the prevalence and incidence. Will fit two statistical models with cross-validation to evaluate the performance characteristics (Brier score, area under curve, sensitivity, specificity, positive and negative predictive values) of SelectMDx in predicting i) HG PCa and ii) any PCa. | At 5-years follow up |
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Inclusion Criteria:
* Age 35-70 years
Capable of providing informed consent
Prognosis of > 5 years if affected by another cancer
Patients need one to meet at least one of the following high genetic risk categories:
Exclusion Criteria:
* Anuria
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Men at high risk for prostate cancer recruited through University of Michigan Comprehensive Cancer Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer AnswerLine | Contact | 1-800-865-1125 | CancerAnswerLine@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Todd M Morgan, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |