Abstract
BACKGROUND: The treatment landscape of systemic third- and later-line therapy in metastatic colorectal cancer (mCRC) continues to evolve. We, therefore, established the Austrian Group of Medical Tumor Therapy (AGMT) mCRC Registry Third-Line and Beyond to characterize clinical outcome with later-line therapies in routine practice and to support embedded translational and radiomic analyses. METHODS: The AGMT mCRC Registry Third-Line and Beyond is a prospective and retrospective, multicenter, national, non-interventional registry of mCRC patients that have received ≥3 palliative systemic therapies. The registry aims to enroll ≥500 mCRC patients at 15 hospitals in Austria. The electronic case report form (eCRF) captures patient, tumor, and treatment characteristics as well as clinical outcome based on medical records. Imaging studies performed during routine care are recorded in an imaging database to enable blinded independent central review and radiomic analyses. This registry includes a biosample database, allowing tumor samples obtained during routine clinical practice to be used for translational research projects. CONCLUSIONS: The AGMT mCRC Registry Third-Line and Beyond will generate real-world evidence on treatment patterns and effectiveness of later-line therapies in mCRC patients. In addition, the platform is designed to serve as a validation resource for clinical, radiomic, and translational research projects. CLINICAL REGISTRY REGISTRATION: www.clinicaltrials.gov identifier is NCT06678919.