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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
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

Full criteria on ClinicalTrials.gov

Sites (84)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Oncologico de Galicia
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A CoruñaSpainRecruiting
Hospital Universitario de A Coruña (CHUAC)
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A CoruñaSpainRecruiting
Complejo Hospitalario Universitario de Albacete
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AlbaceteSpainRecruiting
Hospital Universitario Principe de Asturias
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Alcalá de HenaresSpainRecruiting
Hospital Universitario Mancha Centro
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Alcázar de San JuanSpainRecruiting
Hospital Virgen de Los Lirios
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AlcoySpainRecruiting
Hospital General Universitario de Alicante
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AlicanteSpainRecruiting
Hospital Universitario Torrecárdenas
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AlmeríaSpainRecruiting
Hospital Universitario de La Ribera
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AlziraSpainRecruiting
Hospital Universitario de Badajoz
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BadajozSpainRecruiting
Hospital Universitario de Cruces
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BarakaldoSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitario Basurto
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BilbaoSpainRecruiting
Hospital Universitario De Burgos
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BurgosSpainRecruiting
Hospital San Pedro De Alcántara
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CáceresSpainRecruiting
Hospital General Universitario de Ciudad Real
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Ciudad RealSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital Virgen de la Luz
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CuencaSpainRecruiting
OSI Donostialdea - Onkologikoa
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Donostia / San SebastianSpainRecruiting
Hospital Universitario del Vinalopo
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ElcheSpainRecruiting
Hospital Universitario Virgen de la Arrixaca
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El PalmarSpainRecruiting
Complejo Hospitalario Universitario de Ferrol
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FerrolSpainRecruiting
Hospital Galdakao-Usansolo Ospitalea
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GaldakaoSpainRecruiting
Hospital Universitario de Getafe
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GetafeSpainRecruiting
Hospital Universitario de Cabueñes
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GijónSpainRecruiting
Hospital Universitario Virgen a de las Nieves
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GranadaSpainRecruiting
Hospital Universitario Clínico San Cecilio
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GranadaSpainRecruiting
Hospital Universitario de Guadalajara
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GuadalajaraSpainRecruiting
Hospital Universitario San Jorge
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HuescaSpainRecruiting
Hospital Universitario de Jaén
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JaénSpainRecruiting
Hospital Universitario Jerez De La Frontera
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Jerez de la FronteraSpainRecruiting
Hospital Materno Infantil de Gran Canaria
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Las Palmas de Gran CanariaSpainRecruiting
Hospital Universitario Severo Ochoa
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LeganésSpainRecruiting
Hospital Universitario San Pedro
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LogroñoSpainRecruiting
Hospital Universitario Lucus Augusti
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LugoSpainRecruiting
Hospital Central de la Defensa Gómez Ulla
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital General Mateu Orfila
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MahónSpainRecruiting
Hospital Universitario Puerta de Hierro
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MajadahondaSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
ALTHAIA, Xarxa Assistencial Universitaria de Manresa.
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ManresaSpainNot yet recruiting
Hospital Universitario De Móstoles
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MóstolesSpainRecruiting
Hospital General Universitario Morales Meseguer
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MurciaSpainRecruiting
Complexo Hospitalario Universitario de Ourense
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OurenseSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
Complejo Hospitalario de Palencia
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PalenciaSpainRecruiting
Hospital Universitario Son Llatzer
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Palma de MallorcaSpainRecruiting
Hospital Son Espases
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Palma de MallorcaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainRecruiting
Hospital General de Requena
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RequenaSpainRecruiting
Hospital Universitari Parc Taulí, Sabadell
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SabadellSpainRecruiting
Hospital de Sagunto
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SaguntoSpainRecruiting
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainRecruiting
Hospital Universitario Infanta Sofía
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San SebastiánSpainRecruiting
Hospital Universitari General de Catalunya
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Sant Cugat del VallèsSpainRecruiting
Hospital Clínico Universitario de Santiago CHUS
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Santiago de CompostelaSpainRecruiting
Hospital General de Segovia
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SegoviaSpainRecruiting
Hospital Universitario Virgen Macarena
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SevilleSpainRecruiting
Hospital Universitario Virgen de Valme
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SevilleSpainRecruiting
Hospital Quirón Salud Sagrado Corazón de Sevilla
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SevilleSpainNot yet recruiting
Hospital Universitario Virgen del Rocio
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SevilleSpainRecruiting
Hospital Universitario de Toledo
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ToledoSpainRecruiting
Hospital Universitario de Torrevieja
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TorreviejaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospital Universitario Doctor Peset
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ValenciaSpainRecruiting
Hospital Arnau de Vilanova
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ValenciaSpainRecruiting
Instituto Valenciano de Oncologia
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ValenciaSpainRecruiting
Hospital Clínico Universitario de Valladolid (HCUV)
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ValladolidSpainRecruiting
Hospital Universitario Infanta Leonor
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VallecasSpainRecruiting
Hospital Alvaro Cunqueiro
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VigoSpainRecruiting
Hospital Marina Baixa
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VillajoyosaSpainRecruiting
Hospital Universitario de Álava - Txagorritxu
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Vitoria-GasteizSpainRecruiting
Hospital Lluis Alcanyís de Xàtiva
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XàtivaSpainRecruiting
Complejo Hospitalario Zamora
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ZamoraSpainRecruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainRecruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.