Core variables for real-world clinicogenomic data collection in precision oncology
Background: Precision oncology evidence gaps may be bridged using real-world clinicogenomic data; however, current limitations compromise real-world data collection and evidence generation. We aimed to define a set of precision oncology core variables that can aid in fit-for-purpose real-world data...
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Elsevier
2025-03-01
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| Series: | ESMO Real World Data and Digital Oncology |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2949820125000062 |
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| author | R. Dienstmann A. Hackshaw J.-Y. Blay C. Le Tourneau |
| author_facet | R. Dienstmann A. Hackshaw J.-Y. Blay C. Le Tourneau |
| author_sort | R. Dienstmann |
| collection | DOAJ |
| description | Background: Precision oncology evidence gaps may be bridged using real-world clinicogenomic data; however, current limitations compromise real-world data collection and evidence generation. We aimed to define a set of precision oncology core variables that can aid in fit-for-purpose real-world data collection to be used for a range of purposes and by various stakeholders based on the approach adopted when designing the WAYFIND-R registry (NCT04529122). Materials and methods: A panel of precision oncology experts created a list of variables based on standard dictionaries and vocabularies, which was aligned with the European Medical Agency’s draft guidelines for registry-based studies. A list of core variables was selected from the initial broad list of variables. Results: The initial overall list (∼500 variables) was consolidated to ∼150 variables that covered the entirety of the patient journey in oncology. The panel gave highest priority to patient demographics, socioeconomic information and comorbidities, cancer details, molecular information, particularly predictive biomarkers in routine use and next-generation sequencing technical aspects, systemic cancer therapies and other treatments, outcome assessments and survival outcomes. Conclusions: The core oncology variables represent a harmonized list of key clinicogenomic data elements that can be collected during a patient’s journey in oncology and leveraged for their primary intended purpose of molecular tumor board decision making, and might be used for further secondary research purposes, if legal requirements allow. Definition of this list of core variables will help generate evidence from research- or regulatory-oriented precision oncology studies by ensuring synergy, dataset connectivity, and interoperability across different data. |
| format | Article |
| id | doaj-art-eed914bab73a4245ad12ef563cae438d |
| institution | OA Journals |
| issn | 2949-8201 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | ESMO Real World Data and Digital Oncology |
| spelling | doaj-art-eed914bab73a4245ad12ef563cae438d2025-08-20T02:19:23ZengElsevierESMO Real World Data and Digital Oncology2949-82012025-03-01710011710.1016/j.esmorw.2025.100117Core variables for real-world clinicogenomic data collection in precision oncologyR. Dienstmann0A. Hackshaw1J.-Y. Blay2C. Le Tourneau3OC Precision Medicina, Oncoclínicas & Co, São Paulo, Brazil; PhD Program, Doctoral School, University of Vic—Central University of Catalonia, Barcelona, Spain; Oncology Data Science, Vall d’Hebron Institute of Oncology, Barcelona, Spain; Correspondence to: Dr Rodrigo Dienstmann, Oncology Data Science, Vall d’Hebron Institute of Oncology, Centro Cellex, Carrer de Natzaret, 115-117, Horta-Guinardó, Barcelona 08035, Spain. Tel: +34 654624905Cancer Research UK and UCL Cancer Trials Centre, University College London, London, UKCentre Léon Bérard and Université Claude Bernard, Lyon, FranceInstitut Curie, Department of Drug Development and Innovation (D3i), Paris-Saclay University, Paris, FranceBackground: Precision oncology evidence gaps may be bridged using real-world clinicogenomic data; however, current limitations compromise real-world data collection and evidence generation. We aimed to define a set of precision oncology core variables that can aid in fit-for-purpose real-world data collection to be used for a range of purposes and by various stakeholders based on the approach adopted when designing the WAYFIND-R registry (NCT04529122). Materials and methods: A panel of precision oncology experts created a list of variables based on standard dictionaries and vocabularies, which was aligned with the European Medical Agency’s draft guidelines for registry-based studies. A list of core variables was selected from the initial broad list of variables. Results: The initial overall list (∼500 variables) was consolidated to ∼150 variables that covered the entirety of the patient journey in oncology. The panel gave highest priority to patient demographics, socioeconomic information and comorbidities, cancer details, molecular information, particularly predictive biomarkers in routine use and next-generation sequencing technical aspects, systemic cancer therapies and other treatments, outcome assessments and survival outcomes. Conclusions: The core oncology variables represent a harmonized list of key clinicogenomic data elements that can be collected during a patient’s journey in oncology and leveraged for their primary intended purpose of molecular tumor board decision making, and might be used for further secondary research purposes, if legal requirements allow. Definition of this list of core variables will help generate evidence from research- or regulatory-oriented precision oncology studies by ensuring synergy, dataset connectivity, and interoperability across different data.http://www.sciencedirect.com/science/article/pii/S2949820125000062precision oncologyreal-world datasolid tumorsnext-generation sequencingmolecular tumor boards |
| spellingShingle | R. Dienstmann A. Hackshaw J.-Y. Blay C. Le Tourneau Core variables for real-world clinicogenomic data collection in precision oncology ESMO Real World Data and Digital Oncology precision oncology real-world data solid tumors next-generation sequencing molecular tumor boards |
| title | Core variables for real-world clinicogenomic data collection in precision oncology |
| title_full | Core variables for real-world clinicogenomic data collection in precision oncology |
| title_fullStr | Core variables for real-world clinicogenomic data collection in precision oncology |
| title_full_unstemmed | Core variables for real-world clinicogenomic data collection in precision oncology |
| title_short | Core variables for real-world clinicogenomic data collection in precision oncology |
| title_sort | core variables for real world clinicogenomic data collection in precision oncology |
| topic | precision oncology real-world data solid tumors next-generation sequencing molecular tumor boards |
| url | http://www.sciencedirect.com/science/article/pii/S2949820125000062 |
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