Recommendations for the collection and annotation of biosamples for analysis of biomarkers in neurofibromatosis and schwannomatosis clinical trials

Sundby, R. Taylor, Rhodes, Steven D., Komlodi-Pasztor, Edina, Sarnoff, Herb, Grasso, Vito, Upadhyaya, Meena, Kim, AeRang, Evans, D. Gareth, Blakeley, Jaishri O., Hanemann, C. Oliver and Bettegowda, Chetan 2024. Recommendations for the collection and annotation of biosamples for analysis of biomarkers in neurofibromatosis and schwannomatosis clinical trials. Clinical Trials 21 (1) , pp. 40-50. 10.1177/17407745231203330

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Abstract

Introduction Neurofibromatosis 1 and schwannomatosis are characterized by potential lifelong morbidity and life-threatening complications. To date, however, diagnostic and predictive biomarkers are an unmet need in this patient population. The inclusion of biomarker discovery correlatives in neurofibromatosis 1/schwannomatosis clinical trials enables study of low-incidence disease. The implementation of a common data model would further enhance biomarker discovery by enabling effective concatenation of data from multiple studies. Methods The Response Evaluation in Neurofibromatosis and Schwannomatosis biomarker working group reviewed published data on emerging trends in neurofibromatosis 1 and schwannomatosis biomarker research and developed recommendations in a series of consensus meetings. Results Liquid biopsy has emerged as a promising assay for neurofibromatosis 1/schwannomatosis biomarker discovery and validation. In addition, we review recommendations for a range of biomarkers in clinical trials, neurofibromatosis 1/schwannomatosis–specific data annotations, and common data models for data integration. Conclusion These Response Evaluation in Neurofibromatosis and Schwannomatosis consensus guidelines are intended to provide best practices for the inclusion of biomarker studies in neurofibromatosis 1/schwannomatosis clinical trials, data, and sample annotation and to lay a framework for data harmonization and concatenation between trials.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Publisher:	SAGE Publications
ISSN:	1740-7745
Date of First Compliant Deposit:	3 May 2024
Date of Acceptance:	31 October 2023
Last Modified:	05 Jul 2024 15:47
URI:	https://orca.cardiff.ac.uk/id/eprint/168703

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