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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Cedars-Sinai Medical Center | OTHER |
| VA Medical Center-West Los Angeles | FED |
| VA Long Beach Healthcare System |
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This study will replicate/validate the risk prediction model developed for the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study in a more diverse patient population to assess generalizability of the model as well as evaluate the relative contribution of the Decipher Prostate Cancer Test and ProstateNext Test from Ambry Genetics, to the risk prediction model for estimating treatment outcomes, and thereby improve personalization of treatment options.
The study will contribute a replicable model for improving risk prediction from patient characteristics, clinical severity indicators, and genomic tests to aid in personalizing treatment. The proposed registry would also allow future comparisons of the gene expression used in other competing commercial test. The addition of the suggested genomic classifier and its associations with other patient and clinical characteristics will enhance the ability of future studies, analogous to CEASAR, to accurately predict the risk of tumor aggressiveness in prostate cancer.
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| Measure | Description | Time Frame |
|---|---|---|
| Prostate-Cancer-specific change in quality of life | Quality of life is measured by the Expanded Prostate Cancer Index Composite (EPIC). The Expanded Prostate Cancer Index Composite [EPIC] is a validated instrument for measuring disease-specific function/ The domain scores range from 0 to 100, with higher scores representing better function. Patients will be asked to complete the questionnaires during a consultation visit or remotely. EPIC scores will be collected at baseline, 6 month follow up, and at 12 month follow up via the questionnaire. EPIC scores from each time point will then be compared to look at the change in quality of life over the duration of the study. | Day of enrollment, 6-months, and 12-months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of cancer | Recurrence will be recorded from data abstraction from the electronic medical records (EMR). | EMR data abstraction around the 6-month time point after enrollment |
| Complications of treatment |
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Inclusion Criteria:
Exclusion Criteria:
Since this study is working with prostate cancer, our cohort will only be males.
Our study population will be selected from clinics at 5 major southern California hospitals including: University of California, Irvine, University of California, Los Angeles, Cedars-Sinai Medical Center, Veterans Affair Healthcare Center Long Beach, and Veterans Affair Healthcare Center West Los Angeles.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheldon Greenfield, M.D. | Contact | 949-824-7286 | sgreenfi@uci.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sheldon Greenfield | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Recruiting | Irvine | California | 92697 | United States | |
De-identified individual patient data for all primary and secondary outcome measures will be consolidated into one database and be made available to all participating research sites.
Data will be available within 6 months of study completion
Data access will only be allowed for the principal investigators from each research site.
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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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| FED |
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De-identified specimens stored.
Complications of treatment will be measured using general scales for identifying complications and severity (the Clavien system) as well as assessment of a priori identified complications that are known to occur with prostate cancer care. This information will be collected from electronic medical records.
| EMR data abstraction around the 6-month time point after enrollment |
| Veterans Affair Long Beach Healthcare System |
| Recruiting |
| Long Beach |
| California |
| 90822 |
| United States |
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
| Veterans Affair West Los Angeles Healthcare System | Recruiting | West Los Angeles | California | 90073 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |