Great: A Multicentric Cohort Of Advanced Ovarian Cancer (Aoc) Treated In Real Life With Prospective Collection Of Clinical Data, Tumor Sample, And Biomarkers (Tbrca, Hrd) Including Genomic Putative Theranostic Markers: A Gineco Study

In AOC, tumor genomic analyses such as testing for tumor BRCA mutation (tBRCAm) and homologous recombination repair deficiency (HRD) have become essential to select patients (pts) who will derive the greatest benefit from maintenance PARP inhibitor treatment, particularly in first-line. However, a better understanding of specific genomic alterations beyond BRCA and their impact on disease progression is of a critical importance for the next generation drug development and patient outcome improvement. The main objective of GREAT is to build a large database that will allows to correlate the real-life clinical and evolutionary characteristics of AOC pts according to genomic and molecular tumor abnormalities by setting up a tight collaborative network between clinicians, pathologists, biologists and researchers. Eligible pts will have 1st line AOC (FIGO stage 3 or 4), nonmucinous epithelial OC and FFPE tumor specimen available. We planned to include 4500 patients to be able to analyze subgroups representing 1% of all pts (taking account of a dropout rate of 30% secondary to failure of biological analysis or inadequate follow-up). Gene panel tested is described below.Table: 821TiPGene panelMinimal Core panelBRCA1 BRCA2 RAD51C RAD51DExtended panelHRD genes with non-rare and potentially functional mutationsFANCA CDK12 NBNHRD genes with rare or unproven functional mutationsATM CHEK2 BRIP1 PALB2 Others genesOther genes with potentially actionable mutationsBRAF PI3KCA ARID1A Other targets Open table in a new tab HRD is assessed with Myriad myChoice CDx PLUS® test. Our secondary objectives aim to assess the implementation of tBRCAm test on a nationwide scale as recommended by the French National Cancer institute (INCa) and to participate in the development of future therapeutics by constituting a bank of tumor samples that will allow translational exploratory research. First phase of GREAT will be completed by 2022 with a cohort of 1500 AOC pts treated in the real life with an invaluable collection of biomarkers, clinical data and tumor sample availability. The GREAT cohort will offer a unique opportunity for current and future drug development evaluation. NCT04027868. ARCAGY-GINECO.