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Validation Study on the Impact of Decipher® Testing - VANDAAM Study

NCT02723734 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Kosj Yamoah, M.D., Ph.D. · H. Lee Moffitt Cancer Center and Research Institute

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-13
Primary Completion
2023-07-06
Completion
2026-09-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02723734 on ClinicalTrials.gov