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NCT02723734 · ClinicalTrials.gov registry record
Validation Study on the Impact of Decipher® Testing - VANDAAM Study
A clinical trial of Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- 240
- Enrollment target
- 3
- Study locations
NCT02723734: Active study of Prostate Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02723734 is a study of Prostate Cancer that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 240 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (61% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02723734, a study of Prostate Cancer, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- 240 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
PSA failure defined for first line treatment options of Radical Prostatectomy (RP) and Radiotherapy (RT) in accordance with National Comprehensive Cancer Network (NCCN) guidelines: PSA failure for RP is defined by an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence); or failure of PSA to fall to undetectable levels (PSA persistence). PSA failure for treatment with RT is defined as PSA increase by 2 ng/mL or more above the
Conditions Studied
Interventions
- OTHER Decipher® Testing
Study Locations (3)
Florida
- Bay Pines VA Health care System - Bay Pines
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
- James A. Haley VA Hospital - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2016-04-13 |
| Est. Completion | 2026-09-22 |
What the registry record for NCT02723734 still lists
NCT02723734 is an observational study that tracks outcomes without assigning an intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Decipher® Testing is the first listed.
NCT02723734 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02723734 about?
NCT02723734 is a clinical study titled "Validation Study on the Impact of Decipher® Testing - VANDAAM Study". 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 fro...
What is the current status of trial NCT02723734?
This trial is currently active not recruiting. The enrollment target is 240 participants. The study started on 2016-04-13. Estimated completion is 2026-09-22.
What conditions does trial NCT02723734 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT02723734?
The interventions under investigation include: Decipher® Testing (OTHER).
Who is sponsoring clinical trial NCT02723734?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02723734 being conducted?
This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02723734's enrollment target sits among peer trials
240 193rd of 735 higher than 542 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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