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Validation Study on the Impact of Decipher® Testing - VANDAAM Study
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Summary
The primary purpose of this study is to determine whether a tumor test recently developed by GenomeDx Biosciences known as Decipher® can predict aggressive prostate cancer with the same accuracy in African-American men (AAM) as in non-African-American men (NAAM). The Decipher® test was developed from samples derived mainly from men of European origins and little is known about its performance in AAM. It is important to study whether this test can be used in AAM who are known to experience the highest rates of prostate cancer as well as death from prostate cancer. The use of the Decipher® test result to predict how well a patient will do before treatment may make it possible for doctors to distinguish aggressive disease from low risk prostate cancer and modify treatment accordingly. Thus, patients that do not need additional therapies may be spared from unnecessary side effects and those that are at risk may be provided with more aggressive therapy to improve survival. This study is being done to learn whether the Decipher test can really affect these outcomes.
Official title: A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men With Prostate Cancer (VANDAAM Study)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
240
Start Date
2016-04-13
Completion Date
2026-09-22
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Decipher® Testing
Decipher® Prostate Cancer Classifier (Post-Op and Biopsy), a Genomic Classifier (GC) test. Biopsy and prostatectomy specimens will be collected for GC testing.
Locations (3)
Bay Pines VA Health care System
Bay Pines, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
James A. Haley VA Hospital
Tampa, Florida, United States