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Review
. 2019 Feb 26;8(3):200.
doi: 10.3390/cells8030200.

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

Marina Bagnoli  1 , Ting Yan Shi  2 , Charlie Gourley  3 , Paul Speiser  4 , Alexander Reuss  5 , Hans W Nijman  6 , Carien L Creutzberg  7 , Suzy Scholl  8 , Anastassia Negrouk  9 , Mark F Brady  10 , Kosei Hasegawa  11 , Katsutoshi Oda  12 , Iain A McNeish  13 , Elise C Kohn  14 , Amit M Oza  15 , Helen MacKay  16 , David Millan  17 , Katherine Bennett  18 , Clare Scott  19 , Delia Mezzanzanica  20
Affiliations
Review

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

Marina Bagnoli et al. Cells. .

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.

Keywords: biomarkers definition; gynecological cancers; precision medicine; samples collection; translational studies design.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Paradigm for use and definition of biomarkers in clinical trials. Validation of a biomarker to be considered integral to a clinical trial from its pre-clinical definition. Slide courtesy of Dr. A. Oza from his presentation to the Gynecologic Cancer InterGroup (GCIG) Translational Research brainstorming day.
Figure 2
Figure 2
Application of integral, integrated and explorative biomarker analysis in the ENGOT-OV-NOVA16 trial design. (gBRCA: germline BRCA; mut: mutated; HRD: homologous recombination deficiency).
See this image and copyright information in PMC

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