Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions

Marina Bagnoli, Ting Yan Shi, Charlie Gourley, Paul Speiser, Alexander Reuss, Hans W. Nijman, Carien L. Creutzberg, Suzy Scholl, Anastassia Negrouk, Mark F. Brady, Kosei Hasegawa, Katsutoshi Oda, Iain A. McNeish, Elise C. Kohn, Amit M. Oza, Helen MacKay, David Millan, Katherine Bennett, Clare Scott, Delia Mezzanzanica

Research output: Contribution to journalArticle

Abstract

In the era of personalized medicine, the introduction of translational studies in clinical trials has substantially increased their costs, but provides the possibility of improving the productivity of trials with a better selection of recruited patients. With the overall goal of creating a roadmap to improve translational design for future gynecological cancer trials and of defining translational goals, a main discussion was held during a brainstorming day of the Gynecologic Cancer InterGroup (GCIG) Translational Research Committee and overall conclusions are here reported. A particular emphasis was dedicated to the new frontier of the immunoprofiling of gynecological cancers. The discussion pointed out that to maximize patients' benefit, translational studies should be integral to clinical trial design with standardization and optimization of procedures including a harmonization program of Standard Operating Procedures. Pathology-reviewed sample collection should be mandatory and ensured by dedicated funding. Biomarker validation and development should be made public and transparent to ensure rapid progresses with positive outcomes for patients. Guidelines/templates for patients' informed consent are needed. Importantly for the public, recognized goals are to increase the involvement of advocates and to improve the reporting of translational data in a forum accessible to patients.
Original languageEnglish
JournalCells
Volume8
Issue number3
DOIs
Publication statusPublished - 2019

Keywords

  • Female
  • Humans
  • Biomarkers, Tumor
  • Consensus
  • Clinical Trials as Topic
  • Precision Medicine
  • Genital Neoplasms, Female
  • precision medicine
  • biomarkers definition
  • gynecological cancers
  • samples collection
  • Translational Medical Research
  • translational studies design

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  • Cite this

    Bagnoli, M., Shi, T. Y., Gourley, C., Speiser, P., Reuss, A., Nijman, H. W., Creutzberg, C. L., Scholl, S., Negrouk, A., Brady, M. F., Hasegawa, K., Oda, K., McNeish, I. A., Kohn, E. C., Oza, A. M., MacKay, H., Millan, D., Bennett, K., Scott, C., & Mezzanzanica, D. (2019). Gynecological Cancers Translational, Research Implementation, and Harmonization: Gynecologic Cancer InterGroup Consensus and Still Open Questions. Cells, 8(3). https://doi.org/10.3390/cells8030200