التفاصيل البيبلوغرافية
| العنوان: |
Recommendations for the collection and annotation of biosamples for analysis of biomarkers in neurofibromatosis and schwannomatosis clinical trials. |
| المؤلفون: |
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, Bettegowda, Chetan |
| المصدر: |
Clinical Trials; Feb2024, Vol. 21 Issue 1, p40-50, 11p |
| مصطلحات موضوعية: |
BIOMARKERS, CLINICAL trials, SCHWANNOMAS, MEDICAL protocols, NEUROFIBROMATOSIS, BODY fluid examination, PREDICTION models |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
|
Copyright of Clinical Trials is the property of Sage Publications, Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
