Prospective Real-World Gynaecological Cancer Clinical Registry with Associated Biospecimens: A Collaborative Model to Promote Translational Research between GEICO and the Spanish Biobank Network

SIMPLE SUMMARY: This is a collaborative approach between two multicentre structures, the Spanish Group of Ovarian Cancer Research (GEICO) and the Spanish Biobank Network (RNBB), for collecting high-quality clinical data and associated biospecimens from gynaecological patients in the context of a virtual clinical registry (VCR). The model described herein defines the mode of operation of this initiative and represents a win-win example between multicentre structures that will contribute to the success of translational research in gynaecological cancer. As of December 2021, 30 active sites have recruited a total of 655 patients in the GEICO VCR, distributed in the following cohorts: Ovarian Cancer (377), Endometrial Cancer (206), Cervical Cancer (67), and Rare Tumours (5). The main type of associated biospecimens are formalin-fixed and paraffin-embedded tissue, plasma, serum, and buffy-coat. ABSTRACT: Patient registries linked to biorepositories constitute a valuable asset for clinical and translational research in oncology. The Spanish Group of Ovarian Cancer Research (GEICO), in collaboration with the Spanish Biobank Network (RNBB), has developed a multicentre, multistakeholder, prospective virtual clinical registry (VCR) associated with biobanks for the collection of real-world data and biological samples of gynaecological cancer patients. This collaborative project aims to promote research by providing broad access to high-quality clinical data and biospecimens for future research according to the needs of investigators and to increase diagnostic and therapeutic opportunities for gynaecological cancer patients in Spain. The VCR will include the participation of more than 60 Spanish hospitals entering relevant clinical information in harmonised electronic case report forms (eCRFs) in four different cohorts: ovarian, endometrial, cervical, and rare gynaecological cancers (gestational trophoblastic disease). Initial data for the cases included till December 2021 are presented. The model described herein establishes a real-world win-win collaboration between multicentre structures, promoted and supported by GEICO, that will contribute to the success of translational research in gynaecological cancer.