NCT06724159Recruiting
Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
PRINCIS Study ("Public Health Clinical Research Project"): Observational Study of the Effectiveness of Drugs Funded by the National Health System for Genitourinary Tumors.
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 4 Dec 2024
- Start date
- 13 Dec 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Diseases
- Prostate cancer, Kidney cancer, Bladder cancer
- NCT number
- NCT06724159
What you commit to
- Study type: Observational
- Planned participants: 500
- From 13 Dec 2024 to the primary completion date, Dec 2027
- 84 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (84)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Oncologico de Galicia Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Universitario de A Coruña (CHUAC) Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Complejo Hospitalario Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Recruiting |
| Hospital Universitario Principe de Asturias Coordinator of this site? Confirm its status | Alcalá de Henares | Spain | Recruiting |
| Hospital Universitario Mancha Centro Coordinator of this site? Confirm its status | Alcázar de San Juan | Spain | Recruiting |
| Hospital Virgen de Los Lirios Coordinator of this site? Confirm its status | Alcoy | Spain | Recruiting |
| Hospital General Universitario de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital Universitario Torrecárdenas Coordinator of this site? Confirm its status | Almería | Spain | Recruiting |
| Hospital Universitario de La Ribera Coordinator of this site? Confirm its status | Alzira | Spain | Recruiting |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Recruiting |
| Hospital Universitario De Burgos Coordinator of this site? Confirm its status | Burgos | Spain | Recruiting |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Recruiting |
| Hospital General Universitario de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Virgen de la Luz Coordinator of this site? Confirm its status | Cuenca | Spain | Recruiting |
| OSI Donostialdea - Onkologikoa Coordinator of this site? Confirm its status | Donostia / San Sebastian | Spain | Recruiting |
| Hospital Universitario del Vinalopo Coordinator of this site? Confirm its status | Elche | Spain | Recruiting |
| Hospital Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | El Palmar | Spain | Recruiting |
| Complejo Hospitalario Universitario de Ferrol Coordinator of this site? Confirm its status | Ferrol | Spain | Recruiting |
| Hospital Galdakao-Usansolo Ospitalea Coordinator of this site? Confirm its status | Galdakao | Spain | Recruiting |
| Hospital Universitario de Getafe Coordinator of this site? Confirm its status | Getafe | Spain | Recruiting |
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Recruiting |
| Hospital Universitario Virgen a de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitario de Guadalajara Coordinator of this site? Confirm its status | Guadalajara | Spain | Recruiting |
| Hospital Universitario San Jorge Coordinator of this site? Confirm its status | Huesca | Spain | Recruiting |
| Hospital Universitario de Jaén Coordinator of this site? Confirm its status | Jaén | Spain | Recruiting |
| Hospital Universitario Jerez De La Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Recruiting |
| Hospital Materno Infantil de Gran Canaria Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Recruiting |
| Hospital Universitario Severo Ochoa Coordinator of this site? Confirm its status | Leganés | Spain | Recruiting |
| Hospital Universitario San Pedro Coordinator of this site? Confirm its status | Logroño | Spain | Recruiting |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Recruiting |
| Hospital Central de la Defensa Gómez Ulla Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Mateu Orfila Coordinator of this site? Confirm its status | Mahón | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| ALTHAIA, Xarxa Assistencial Universitaria de Manresa. Coordinator of this site? Confirm its status | Manresa | Spain | Not yet recruiting |
| Hospital Universitario De Móstoles Coordinator of this site? Confirm its status | Móstoles | Spain | Recruiting |
| Hospital General Universitario Morales Meseguer Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Complexo Hospitalario Universitario de Ourense Coordinator of this site? Confirm its status | Ourense | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Complejo Hospitalario de Palencia Coordinator of this site? Confirm its status | Palencia | Spain | Recruiting |
| Hospital Universitario Son Llatzer Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Recruiting |
| Hospital Son Espases Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Hospital General de Requena Coordinator of this site? Confirm its status | Requena | Spain | Recruiting |
| Hospital Universitari Parc Taulí, Sabadell Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| Hospital de Sagunto Coordinator of this site? Confirm its status | Sagunto | Spain | Recruiting |
| Complejo Asistencial Universitario de Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Universitario Infanta Sofía Coordinator of this site? Confirm its status | San Sebastián | Spain | Recruiting |
| Hospital Universitari General de Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Recruiting |
| Hospital Clínico Universitario de Santiago CHUS Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital General de Segovia Coordinator of this site? Confirm its status | Segovia | Spain | Recruiting |
| Hospital Universitario Virgen Macarena Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hospital Universitario Virgen de Valme Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hospital Quirón Salud Sagrado Corazón de Sevilla Coordinator of this site? Confirm its status | Seville | Spain | Not yet recruiting |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Hospital Universitario de Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Recruiting |
| Hospital Universitario de Torrevieja Coordinator of this site? Confirm its status | Torrevieja | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Doctor Peset Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Arnau de Vilanova Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Instituto Valenciano de Oncologia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid (HCUV) Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Vallecas | Spain | Recruiting |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Hospital Marina Baixa Coordinator of this site? Confirm its status | Villajoyosa | Spain | Recruiting |
| Hospital Universitario de Álava - Txagorritxu Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Recruiting |
| Hospital Lluis Alcanyís de Xàtiva Coordinator of this site? Confirm its status | Xàtiva | Spain | Recruiting |
| Complejo Hospitalario Zamora Coordinator of this site? Confirm its status | Zamora | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.