Abstract 854P
Background
Accurate clinical annotations associated with biological samples are crucial for outcome research on real-world data. The purpose of this study is to create a virtual clinical registry (VCR) of gynecological cancer patients, associated with the collection of biological samples through biobanks, with the aim of developing real-world studies and translational research in Spain.
Methods
GEICO VCR is an observational, prospective, multicenter study that will involve over 60 hospitals. It incorporates clinical information and biological samples in 4 different cohorts: ovarian (OC), endometrial (EC), cervical (CC) and rare cancer (RC). Nine centers participated in a pilot study implementing the VCR with the OC module. Inclusion criteria were: 1) women diagnosed with gynecological cancer since March 2019; 2) age ≥ 18 years; 3) written informed consent; 4) access to medical records. Clinical information is collected in 7 data sets: Patient data (anonymized); Diagnosis; Primary Surgery; Chemotherapy; Biobank; Recurrence; Follow-up. The samples collected include formalin-fixed and paraffin-embedded material, fresh frozen tissues, serum and plasma, lymphocytes and ascites. They are stored at the biobanks of each center, using a coding system to link clinical information.
Results
From June 2019 to May 2020 a total of 77 OC registries were included. 77% of the patients were >51 years-old. 91% were epithelial malignant OC, 4% borderline tumors and 5% carcinosarcomas. FIGO stage was: 21% IA-IC3; 3% IIA; 47% IIIA-IIIC; and 25% IVA-IVB. Standard treatment in most of the cases was surgery followed by chemotherapy (carboplatin + paclitaxel), 13 cases received also bevacizumab. 21% of patients were enrolled in a clinical trial, and in 10 cases the homologous recombination status is known (4 positive). Biological samples of all these patients were collected for translational research studies.
Conclusions
The GEICO VCR together with the sample collection through biobanks will be a powerful tool for improving translational research in gynecological cancer. It will allow increasing knowledge about the biological basis of the disease and clinical management in the real-world setting.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Spanish Ovarian Cancer Research Group (GEICO).
Funding
Grupo Español de Investigación en Cáncer de Ovario (GEICO).
Disclosure
M. Mendiola: Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: GSK/Tesaro. J.A. Pérez-Fidalgo: Advisory/Consultancy: Amgen; Advisory/Consultancy: Clovis; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: GSK/Tesaro. I. Romero, A. Herrero, M.J. Rubio: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: GSK/Tesaro; Advisory/Consultancy: Roche; Advisory/Consultancy: Clovis. J.D. Alarcon: Advisory/Consultancy: Clovis; Advisory/Consultancy: GSK/Tesaro. C. Esteban Esteban: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: GSK/Tesaro; Advisory/Consultancy: Roche. G. Marquina Ospina: Advisory/Consultancy: PharmaMar; Advisory/Consultancy: GSK/Tesaro; Advisory/Consultancy: Clovis. A. González Martín: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution), ANITA trial: GSK/Tesaro; Advisory/Consultancy: Clovis; Advisory/Consultancy, Research grant/Funding (institution), ANITA Trial: Roche; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Inmunogen; Advisory/Consultancy: PharmaMar; Advisory/Consultancy: MSD; Advisory/Consultancy: Genmab; Advisory/Consultancy: Oncoinvent. All other authors have declared no conflicts of interest.