Core variables for real-world clinicogenomic data collection in precision oncology

Area of Science:

• Oncology
• Genomics
• Data Science

Background:

• Precision oncology relies on real-world clinicogenomic data, but current limitations hinder effective data collection and evidence generation.
• The WAYFIND-R registry (NCT04529122) approach was used to address these limitations.

Purpose of the Study:

• To define a core set of precision oncology variables for fit-for-purpose real-world data collection.
• To support various stakeholders and a range of data uses.

Main Methods:

• A panel of precision oncology experts developed an initial list of variables based on standard dictionaries and vocabularies.
• The list was aligned with European Medical Agency draft guidelines for registry-based studies.
• A core set of variables was selected from the broader list.

Main Results:

• The initial list of approximately 500 variables was refined to about 150 core variables.
• These variables cover the entire patient journey in oncology.
• Key areas prioritized include demographics, socioeconomic factors, comorbidities, cancer details, molecular information (biomarkers, next-generation sequencing), treatments, and outcomes.

Conclusions:

• The defined core oncology variables provide a harmonized list of essential clinicogenomic data elements.
• These variables facilitate molecular tumor board decision-making and potential secondary research.
• Standardizing these core variables will enhance synergy, connectivity, and interoperability for precision oncology studies.