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| Name | Class |
|---|---|
| MFAR | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRIDA Cohort | Patients with hormone-sensitive prostate carcinoma not castrated who have started treatment with darolutamide in combination with androgen deprivation therapy and docetaxel, from January 1, 2024 |
| |
| NIADY Cohort | Patients with urothelial carcinoma who have started treatment with adjuvant Nivolumab on or after August 1, 2023 |
| |
| EV3aL Cohort | Patients with urothelial carcinoma who have started treatment with Enfortumab Vedotin (EV) on or after January 1, 2024 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| darolutamide | Drug | Darolutamide in combination with androgen deprivation therapy and docetaxel. Following the posology and administration details of its marketing authorization and standard clinical practice |
| Measure | Description | Time Frame |
|---|---|---|
| Progresion-free survival rate at 18 months | For TRIDA substudy. Defined as the percentage of patients alive and free of progression of the disease (estimated by Kaplan-Meier method) at 18 months. Patients without event are censored in their last follow-up | 18 months after the initiation of study treatment |
| Relapse-free survival rate at 24 months | For NIADY substudy. Defined as the percentage of patients alive and with no disease recurrence (estimated by Kaplan-Meier method) at 24 months | 24 months after the first dose of study treatment |
| Overall survival rate at 12 months | For EV3aL substudy Defined as the percentage of patients alive (estimated by Kaplan-Meier method) at 12 months | 12 months after the first dose of study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with genitourinary cancers treated with new therapies following the standard clinical practice
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A Responsible Person Designated by the sponsor | Contact | 0034934344412 | investigacio@mfar.net |
| Name | Affiliation | Role |
|---|---|---|
| José Ángel Arranz Arija, M.D.; Ph.D. | Hospital General Universitario Gregorio Marañón de Madrid | Study Chair |
| Aránzazu González del Alba, M.D.; Ph.D. | Hospital Universitario Puerta de Hierro | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Albacete | Recruiting | Albacete | Albacete | 02006 | Spain |
No IDP sharing is prestablished
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| Nivolumab monotherapy | Drug | Adjuvant nivolumab following after surgical removal of urothelial carcinoma. Following the posology and administration details of its marketing authorization and standard clinical practice |
|
| enfortumab vedotin | Drug | Following the posology and administration details of its marketing authorization and standard clinical practice |
|
| Sergio Vázquez Estévez, M.D.; Ph.D. | Hospital Universitario Lucus Augusti | Study Chair |
| Hospital General Universitario de Alicante | Recruiting | Alicante | Alicante | 03010 | Spain |
|
| Hospital Universitario Torrecárdenas | Recruiting | Almería | Andalusia | 04009 | Spain |
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| Hospital Universitario Reina Sofía | Recruiting | Córdoba | Andalusia | 14004 | Spain |
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| Hospital Universitario Clínico San Cecilio | Recruiting | Granada | Andalusia | 18007 | Spain |
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| Hospital Universitario Virgen a de las Nieves | Recruiting | Granada | Andalusia | 18014 | Spain |
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| Hospital Universitario de Jaén | Recruiting | Jaén | Andalusia | 23007 | Spain |
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| Hospital Universitario Jerez de la Frontera | Recruiting | Jerez de la Frontera | Andalusia | 11407 | Spain |
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| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | Andalusia | 29010 | Spain |
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| Hospital Universitario Virgen Macarena | Recruiting | Seville | Andalusia | 41009 | Spain |
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| Hospital Quirón Salud Sagrado Corazón de Sevilla | Not yet recruiting | Seville | Andalusia | 41013 | Spain |
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| Hospital Universitario Virgen del Rocío | Recruiting | Seville | Andalusia | 41013 | Spain |
|
| Hospital Universitario Virgen de Valme | Recruiting | Seville | Andalusia | 41014 | Spain |
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| Hospital Universitario San Jorge | Recruiting | Huesca | Aragon | 22004 | Spain |
|
| Hospital Clínico Universitario Lozano Blesa | Recruiting | Zaragoza | Aragon | 50009 | Spain |
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| Hospital Universitario Miguel Servet | Recruiting | Zaragoza | Aragon | 50009 | Spain |
|
| Hospital General Mateu Orfila | Recruiting | Mahón | Balearic Islands | 07703 | Spain |
|
| Hospital Son Espases | Recruiting | Palma de Mallorca | Balearic Islands | 07120 | Spain |
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| Hospital Universitario Son Llàtzer | Recruiting | Palma de Mallorca | Balearic Islands | 07198 | Spain |
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| Hospital Universitario de Cruces | Recruiting | Barakaldo | Basque Country | 48903 | Spain |
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| Hospital Universitario Basurto | Recruiting | Bilbao | Basque Country | 48013 | Spain |
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| OSI Donostialdea - Onkologikoa | Recruiting | Donostia / San Sebastian | Basque Country | 20014 | Spain |
|
| Hospital Galdakao-Usansolo Ospitalea | Recruiting | Galdakao | Basque Country | 48960 | Spain |
|
| Hospital Universitario de Álava - Txagorritxu | Recruiting | Vitoria-Gasteiz | Basque Country | 01009 | Spain |
|
| Hospital Materno Infantil de Gran Canaria | Recruiting | Las Palmas de Gran Canaria | Canary Islands | 35016 | Spain |
|
| Hospital Universitario de Burgos | Recruiting | Burgos | Castille and León | 09006 | Spain |
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| Complejo Hospitalario de Palencia | Recruiting | Palencia | Castille and León | 34004 | Spain |
|
| Complejo Asistencial Universitario de Salamanca | Recruiting | Salamanca | Castille and León | 37007 | Spain |
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| Hospital General de Segovia | Recruiting | Segovia | Castille and León | 40002 | Spain |
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| Hospital Clínico Universitario de Valladolid (HCUV) | Recruiting | Valladolid | Castille and León | 47003 | Spain |
|
| Complejo Hospitalario Zamora | Recruiting | Zamora | Castille and León | 49022 | Spain |
|
| Hospital Universitario Mancha Centro | Recruiting | Alcázar de San Juan | Castille-La Mancha | 13600 | Spain |
|
| Hospital General Universitario de Ciudad Real | Recruiting | Ciudad Real | Castille-La Mancha | 13005 | Spain |
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| Hospital Virgen de la Luz | Recruiting | Cuenca | Castille-La Mancha | 16002 | Spain |
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| Hospital Universitario de Guadalajara | Recruiting | Guadalajara | Castille-La Mancha | 19002 | Spain |
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| Hospital del Mar | Recruiting | Barcelona | Catalonia | 08003 | Spain |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Catalonia | 08025 | Spain |
|
| Hospital Universitari Vall d'Hebrón | Recruiting | Barcelona | Catalonia | 08035 | Spain |
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| Hospital Clínic de Barcelona | Recruiting | Barcelona | Catalonia | 08036 | Spain |
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| Althaia Xarxa Assistencial Universitària de Manresa | Not yet recruiting | Manresa | Catalonia | 08243 | Spain |
|
| Hospital Universitari Parc Taulí, Sabadell | Recruiting | Sabadell | Catalonia | 08208 | Spain |
|
| Hospital Universitari General de Catalunya | Recruiting | Sant Cugat Del Vallés | Catalonia | 08195 | Spain |
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| Hospital Universitario de Badajoz | Recruiting | Badajoz | Extremadura | 06080 | Spain |
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| Hospital San Pedro de Alcántara | Recruiting | Cáceres | Extremadura | 10003 | Spain |
|
| Hospital Universitario de A Coruña (CHUAC) | Recruiting | A Coruña | Galicia | 15006 | Spain |
|
| Centro Oncológico de Galicia | Recruiting | A Coruña | Galicia | 15009 | Spain |
|
| Complejo Hospitalario Universitario de Ferrol | Recruiting | Ferrol | Galicia | 15405 | Spain |
|
| Hospital Universitario Lucus Augusti | Recruiting | Lugo | Galicia | 27003 | Spain |
|
| Complexo Hospitalario Universitario de Ourense | Recruiting | Ourense | Galicia | 32005 | Spain |
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| Hospital Clínico Universitario de Santiago ~ CHUS | Recruiting | Santiago de Compostela | Galicia | 15706 | Spain |
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| Hospital Álvaro Cunqueiro | Recruiting | Vigo | Galicia | 36312 | Spain |
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| Hospital Universitario San Pedro | Recruiting | Logroño | La Rioja | 26006 | Spain |
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| Hospital Universitario Príncipe de Asturias | Recruiting | Alcalá de Henares | Madrid | 28805 | Spain |
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| Hospital Universitario de Getafe | Recruiting | Getafe | Madrid | 28905 | Spain |
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| Hospital Universitario Severo Ochoa | Recruiting | Leganés | Madrid | 28914 | Spain |
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| Hospital General Universitario Gregorio Marañon | Recruiting | Madrid | Madrid | 28007 | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Madrid | 28034 | Spain |
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| Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | Madrid | 28040 | Spain |
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| Hospital Central de la Defensa Gómez Ulla | Recruiting | Madrid | Madrid | 28047 | Spain |
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| Hospital Universitario Puerta de Hierro | Recruiting | Majadahonda | Madrid | 28222 | Spain |
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| Hospital Universitario de Móstoles | Recruiting | Móstoles | Madrid | 28935 | Spain |
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| Hospital Universitario Quironsalud Madrid | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
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| Hospital Universitario Infanta Sofía | Recruiting | San Sebastián | Madrid | 28702 | Spain |
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| Hospital Universitario Infanta Leonor | Recruiting | Vallecas | Madrid | 28031 | Spain |
|
| Hospital Universitario Virgen de la Arrixaca | Recruiting | El Palmar | Murcia | 30120 | Spain |
|
| Hospital General Universitario Morales Meseguer | Recruiting | Murcia | Murcia | 30008 | Spain |
|
| Hospital Universitario de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
|
| Hospital Universitario de Cabueñes | Recruiting | Gijón | Principality of Asturias | 33394 | Spain |
|
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
|
| Hospital Virgen de los Lirios | Recruiting | Alcoy | Valencia | 03804 | Spain |
|
| Hospital Universitario de la Ribera | Recruiting | Alzira | Valencia | 46600 | Spain |
|
| Hospital Universitario del Vinalopó | Recruiting | Elche | Valencia | 03293 | Spain |
|
| Hospital General de Requena | Recruiting | Requena | Valencia | 46340 | Spain |
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| Hospital de Sagunto | Recruiting | Sagunto | Valencia | 46520 | Spain |
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| Hospital Universitario de Torrevieja | Recruiting | Torrevieja | Valencia | 03186 | Spain |
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| Instituto Valenciano de Oncología | Recruiting | Valencia | Valencia | 46009 | Spain |
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| Hospital Clínico Universitario de Valencia | Recruiting | Valencia | Valencia | 46010 | Spain |
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| Consorcio Hospital General Universitario de València | Recruiting | Valencia | Valencia | 46014 | Spain |
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| Hospital Arnau de Vilanova | Recruiting | Valencia | Valencia | 46015 | Spain |
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| Hospital Universitario Doctor Peset | Recruiting | Valencia | Valencia | 46017 | Spain |
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| Hospital Universitario y Politécnico La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
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| Hospital Marina Baixa | Recruiting | Villajoyosa | Valencia | 03570 | Spain |
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| Hospital Lluis Alcanyís de Xàtiva | Recruiting | Xàtiva | Valencia | 46800 | Spain |
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| Hospital Universitario de Toledo | Recruiting | Toledo | Spain |
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| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C000607739 | darolutamide |
| C000632577 | enfortumab vedotin |
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