Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02723734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2016-03-15
Brief Title:
Validation Study on the Impact of Decipher Testing - VANDAAM Study
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VANDAAM
Brief 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
Detailed Description:
This is a multisite prospective validation trial Based on a population consisting of 25 AAM and 75 NAAM investigators will actively recruit participants and aim to achieve a 11 enrollment ratio of AAM to NAAM To achieve this low risk AAM will be accrued first and then matching NAAM will be enrolled NAAM men will be matched to AAM on prostate specific antigen PSA at diagnosis
There will be no treatment intervention beyond standard of care SOC and therefore participants will be allowed to choose their definitive treatment option The intent is to enroll low risk and high volume disease burden patients to limit the accrual of patients that would select active surveillance AS
There will be no treatment intervention beyond standard of care SOC and therefore participants will be allowed to choose their definitive treatment option The intent is to enroll low risk and high volume disease burden patients to limit the accrual of patients that would select active surveillance AS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None