Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.

Launched by SPANISH ONCOLOGY GENITO-URINARY GROUP · Dec 4, 2024

Keywords

ClinConnect Summary

The SOGUG-PRINCIS clinical trial is studying how effective certain new drugs are for treating genitourinary cancers, such as those affecting the kidney, bladder, or prostate. This is an observational study, which means it will collect information about patients who are already receiving these medications through the Spanish National Health System. The goal is to see how well these drugs work in real-life situations, outside of controlled clinical trials.

To participate in the study, patients need to be at least 18 years old and have a confirmed diagnosis of genitourinary cancer. They must also have started treatment with a newly funded medication after January 1, 2023, at one of the participating centers. The study will not interfere with their treatment decisions, as those will be made by their doctors before they agree to join the study. Participants can expect that their health information will be collected to help assess the effectiveness of the treatments they are receiving, contributing to a larger understanding of how these drugs perform in everyday healthcare settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥18 years old.
• • Patients granting the ICF unless exemption or exceptions mentioned below.
• • Histological diagnosis of malignant neoplasia originating in the genitourinary system: kidney, renal pelvis, ureter, bladder, prostate, testicle and germinal tissue of other locations, urethra, penis, or seminal vesicles.
• • Patients have started treatment with medications whose positive resolution of financing by the Spanish National Health System for the aforementioned tumors has been after January 1, 2023.
• • Patients have started treatment after the official publication of the positive resolution of financing of the drug under study by the National Health System. This restriction is intended to avoid interference of the study with the marketing authorization processes by the European Medicines Agency, and price and reimbursement negotiations by the Spanish health authorities.
• • Patients have received treatment at the participating center.
• Exclusion Criteria:
• • Patients previously treated at another centre who have subsequently been referred to one of the participating centres. In this case, the patient will be included in the centre where treatment was started, or in the second centre if the first is not part of this study.
• • Patients who do not meet any of the inclusion criteria.
• • Evidence of an express objection by the subject or his/her legal representative to participate in the study.