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Recommended Clinical Context and Patient Context Data Elements for Liquid Biopsy Data Submitted to Data Repositories
Robert L Grossman1,2, Jake Vinson3, Elizabeth Bain4
1Open Commons Consortium, Chicago, Illinois, USA.
Clinical and Translational Science
|April 22, 2025
Summary
This study expands BLOODPAC recommendations by adding 22 clinical and 10 patient context data elements for liquid biopsy submissions. These elements enhance data quality for biomarker validation and research.
Area of Science:
- Biomedical Informatics
- Genomics
- Clinical Research
Background:
- The BloodPAC consortium previously defined 11 essential pre-analytical data elements for liquid biopsy.
- Standardization of liquid biopsy data is crucial for public database submissions and research reproducibility.
Purpose of the Study:
- To expand the minimal data elements for liquid biopsy submissions beyond pre-analytical factors.
- To recommend comprehensive clinical and patient context data elements for liquid biopsy repositories.
Main Methods:
- Building upon the 2020 BLOODPAC recommendations.
- Identifying and defining 22 clinical context data elements.
- Identifying and defining 10 patient context data elements.
Main Results:
- A total of 32 new data elements (22 clinical, 10 patient) are proposed.
- These elements encompass tumor characteristics, disease progression, and patient demographics.
- The expanded dataset aims to improve the utility of liquid biopsy data in public repositories.
Conclusions:
- The proposed data elements are essential for robust biomarker validation using liquid biopsy.
- Enhanced data context will accelerate research and clinical trial applications of liquid biopsy.
- Adoption of these elements will improve the quality and interpretability of liquid biopsy data.
