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Is It Time to Expand Our Definition of “Clinical Utility”?

Currently, genetic tests that predict cancer risk or risk of recurrence in patients who have had their cancer treated with curative intent must have proven “clinical utility” to be recommended by the organizations responsible for publishing the standard-of-care guidelines for cancer care. Based on t...

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Autor principal: Sorscher, Steven
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10108406/
https://www.ncbi.nlm.nih.gov/pubmed/37057688
http://dx.doi.org/10.1177/10732748231170483
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author Sorscher, Steven
author_facet Sorscher, Steven
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description Currently, genetic tests that predict cancer risk or risk of recurrence in patients who have had their cancer treated with curative intent must have proven “clinical utility” to be recommended by the organizations responsible for publishing the standard-of-care guidelines for cancer care. Based on the current definition of clinical utility, most patients are denied testing for cancer-predisposing genes or pathogenic germline variants even though germline testing has been proven as highly accurate in identifying pathogenic germline variant carriers, there are measures recommended to prevent and diagnose early cancers associated with particular PGVs, and disparities in patient access to genetic tests are well described. Similarly, despite dozens of studies demonstrating that detected circulating tumor DNA (ctDNA) after curative intention therapy of different cancer types is a highly accurate biomarker that predicts recurrence, the major organizations that publish guidelines for cancer monitoring after curative intention therapy recommend against using ctDNA assays to detect minimal residual disease and thereby predict recurrence for all solid tumor malignancies. Here, the primary reasons that these genetic tests are considered to lack proven clinical utility and the primary evidence suggesting that a broader definition of clinical utility should be considered are discussed. By expanding the definition of clinical utility, many patients will benefit from the information gained from having these genetic tests.
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spelling pubmed-101084062023-04-18 Is It Time to Expand Our Definition of “Clinical Utility”? Sorscher, Steven Cancer Control Commentary & View Currently, genetic tests that predict cancer risk or risk of recurrence in patients who have had their cancer treated with curative intent must have proven “clinical utility” to be recommended by the organizations responsible for publishing the standard-of-care guidelines for cancer care. Based on the current definition of clinical utility, most patients are denied testing for cancer-predisposing genes or pathogenic germline variants even though germline testing has been proven as highly accurate in identifying pathogenic germline variant carriers, there are measures recommended to prevent and diagnose early cancers associated with particular PGVs, and disparities in patient access to genetic tests are well described. Similarly, despite dozens of studies demonstrating that detected circulating tumor DNA (ctDNA) after curative intention therapy of different cancer types is a highly accurate biomarker that predicts recurrence, the major organizations that publish guidelines for cancer monitoring after curative intention therapy recommend against using ctDNA assays to detect minimal residual disease and thereby predict recurrence for all solid tumor malignancies. Here, the primary reasons that these genetic tests are considered to lack proven clinical utility and the primary evidence suggesting that a broader definition of clinical utility should be considered are discussed. By expanding the definition of clinical utility, many patients will benefit from the information gained from having these genetic tests. SAGE Publications 2023-04-14 /pmc/articles/PMC10108406/ /pubmed/37057688 http://dx.doi.org/10.1177/10732748231170483 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Commentary & View
Sorscher, Steven
Is It Time to Expand Our Definition of “Clinical Utility”?
title Is It Time to Expand Our Definition of “Clinical Utility”?
title_full Is It Time to Expand Our Definition of “Clinical Utility”?
title_fullStr Is It Time to Expand Our Definition of “Clinical Utility”?
title_full_unstemmed Is It Time to Expand Our Definition of “Clinical Utility”?
title_short Is It Time to Expand Our Definition of “Clinical Utility”?
title_sort is it time to expand our definition of “clinical utility”?
topic Commentary & View
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10108406/
https://www.ncbi.nlm.nih.gov/pubmed/37057688
http://dx.doi.org/10.1177/10732748231170483
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