A multicenter clinical registry with associated biological samples of gynecological cancer patients: Pilot study of the Spanish Ovarian Cancer Research Group (GEICO 81-T)

Abstract

Background: Accurate clinical annotations associated with biological samples are crucial for outcome research on real-world data. This study aims to create a virtual clinical registry (VCR) of gynecological cancer patients, associated with the collection of biological samples through biobanks, to support real-world studies and translational research in Spain. Methods: GEICO VCR is an observational, prospective, multicenter study involving over 60 hospitals, integrating clinical information and biological samples into four cohorts: ovarian cancer (OC), endometrial cancer (EC), cervical cancer (CC), and rare cancers (RC). A pilot study implementing the OC module was conducted in nine centers. Inclusion criteria were: 1) women diagnosed with gynecological cancer since March 2019; 2) age ≥18 years; 3) written informed consent; and 4) access to medical records. Clinical information is collected across seven data sets: Patient data (anonymized), Diagnosis, Primary Surgery, Chemotherapy, Biobank, Recurrence, and Follow-up. Collected samples include formalin-fixed and paraffin-embedded material, fresh frozen tissues, serum and plasma, lymphocytes, and ascites, which are stored at each center’s biobank using a coding system that links the samples to clinical information.