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Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study
Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evalua...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi Publishing Corporation
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944073/ https://www.ncbi.nlm.nih.gov/pubmed/27446211 http://dx.doi.org/10.1155/2016/5325762 |
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author | Plasseraud, Kristen Meldi Cook, Robert W. Tsai, Tony Shildkrot, Yevgeniy Middlebrook, Brooke Maetzold, Derek Wilkinson, Jeff Stone, John Johnson, Clare Oelschlager, Kristen Aaberg, Thomas M. |
author_facet | Plasseraud, Kristen Meldi Cook, Robert W. Tsai, Tony Shildkrot, Yevgeniy Middlebrook, Brooke Maetzold, Derek Wilkinson, Jeff Stone, John Johnson, Clare Oelschlager, Kristen Aaberg, Thomas M. |
author_sort | Plasseraud, Kristen Meldi |
collection | PubMed |
description | Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p = 0.003) with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher's exact test p = 2.1 × 10(−13) and p = 0.04, resp.). The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920). |
format | Online Article Text |
id | pubmed-4944073 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Hindawi Publishing Corporation |
record_format | MEDLINE/PubMed |
spelling | pubmed-49440732016-07-21 Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study Plasseraud, Kristen Meldi Cook, Robert W. Tsai, Tony Shildkrot, Yevgeniy Middlebrook, Brooke Maetzold, Derek Wilkinson, Jeff Stone, John Johnson, Clare Oelschlager, Kristen Aaberg, Thomas M. J Oncol Research Article Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p = 0.003) with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher's exact test p = 2.1 × 10(−13) and p = 0.04, resp.). The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920). Hindawi Publishing Corporation 2016 2016-06-30 /pmc/articles/PMC4944073/ /pubmed/27446211 http://dx.doi.org/10.1155/2016/5325762 Text en Copyright © 2016 Kristen Meldi Plasseraud et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Plasseraud, Kristen Meldi Cook, Robert W. Tsai, Tony Shildkrot, Yevgeniy Middlebrook, Brooke Maetzold, Derek Wilkinson, Jeff Stone, John Johnson, Clare Oelschlager, Kristen Aaberg, Thomas M. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study |
title | Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study |
title_full | Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study |
title_fullStr | Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study |
title_full_unstemmed | Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study |
title_short | Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study |
title_sort | clinical performance and management outcomes with the decisiondx-um gene expression profile test in a prospective multicenter study |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944073/ https://www.ncbi.nlm.nih.gov/pubmed/27446211 http://dx.doi.org/10.1155/2016/5325762 |
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