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

Официальное название

PRINCIS Study ("Public Health Clinical Research Project"): Observational Study of the Effectiveness of Drugs Funded by the National Health System for Genitourinary Tumors.

Обзор

SOGUG-PRINCIS is a retrospective (regarding patient inclusion) and prospective follow-up, epidemiological, non-interventional, non-blinded, non-randomized, multicenter, national observational study with drugs. This study will collect data from patients with genitourinary tumors to analyze the effectiveness under routine clinical practice conditions of drugs recently approved for funding in the Spanish National Health System. In all cases, the decision to start treatment will be made prior to and independently of participation in the study, which will be limited to subsequently collecting the data necessary to assess the objectives of the study. This study will serve as a registry for genitourinary cancers. Every time a new drug will be authorized, a new subproject with a primary endpoint will be opened to recruitment. The substudy will try to validate with real-world data the endpoints reported in the phase III clinical trials that led to the marketin authorization.

Вмешательства

• Препарат darolutamide
  Darolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice
• Препарат Nivolumab monotherapy
  Adjuvant nivolumab following after surgical removal of urothelial carcinoma. Following the posology and administration details of its marketing authorization and standard clinical practice
• Препарат enfortumab vedotin
  Following the posology and administration details of its marketing authorization and standard clinical practice

Первичные конечные точки

• Progresion-free survival rate at 18 months [Срок оценки: 18 months after the initiation of study treatment]
• Relapse-free survival rate at 24 months [Срок оценки: 24 months after the first dose of study treatment]
• Overall survival rate at 12 months [Срок оценки: 12 months after the first dose of study treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 84 центра

• Complejo Hospitalario Universitario de Albacete — Albacete
• Hospital General Universitario de Alicante — Alicante
• Hospital Universitario Torrecárdenas — Almería
• Hospital Universitario Reina Sofía — Córdoba
• Hospital Universitario Clínico San Cecilio — Granada
• Hospital Universitario Virgen a de las Nieves — Granada
• Hospital Universitario de Jaén — Jaén
• Hospital Universitario Jerez de la Frontera — Jerez de la Frontera
• … и ещё 76 центров

Идентификаторы

NCT: NCT06724159 · SOGUG-PRINCIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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