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This is an observational, multicentre epidemiological study with a longitudinal cohort in which information will be retrieved from medical records of patients with advanced metastatic or unresectable melanoma at first diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Melanoma | Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8, 2018. First diagnosis is understood as:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily Clinical Practice | Other | The assignment of a patient to a specific therapeutic strategy will not be decided in advance by the study protocol, but will be determined by the usual clinical practice of medicine, and the decision to prescribe a specific treatment will be clearly dissociated from the decision to include a patient in the study. No intervention will be applied to patients, either diagnostic or follow-up, other than the usual clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Sample Characteristics | Sociodemographic and disease characteristics of patients diagnosed with stage III, metastatic or unresectable melanoma at first diagnosis. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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A 'case' is defined as any patient, diagnosed, treated, or followed in the different health centres where reporting physicians authorised by the GEM group work, who meets the inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A responsible person designated by the sponsor | Contact | +34 93 434 44 12 | investigacion@mfar.net | |
| Responsible person designated by the sponsor | Contact | +34 93 434 44 12 | investigacion@mfar.net |
| Name | Affiliation | Role |
|---|---|---|
| Iván Márquez Rodas, M.D. | Hospital General Universitario Gregorio Marañón | Study Chair |
| Salvador Martín Algarra, M.D. | Clínica Universidad de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Virgen de los Lirios | Recruiting | Alcoy | Alicante | 03804 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41420791 | Derived | Cerezuela-Fuentes P, Pinero-Madrona A, Munoz-Couselo E, Manzano JL, Berciano-Guerrero MA, Majem M, Espinosa E, Soria A, Ayala de Miguel P, Garcia Castano A, Crespo G, Gutierrez Sanz L, Aguado de la Rosa C, Fernandez-Morales LA, Puertolas T, Fra Rodriguez J, Rodriguez de la Borbolla M, Bellido L, Lopez Castro R, Navarro Perez V, Garcia Arroyo FR, Villa Guzman JC, Campos Balea B, Hernandez B, Martin Algarra S, Marquez-Rodas I. Title: Characterization of Melanoma of Unknown Primary in the Era of Immunotherapy and Targeted Therapy in Spain: Results from the Prospective Real World Study GEM 1801. Clin Transl Oncol. 2026 Jun;28(6):2377-2385. doi: 10.1007/s12094-025-04164-w. Epub 2025 Dec 20. | |
| 41313559 |
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| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | Andalusia | Spain |
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| Onconogranada | Not yet recruiting | Granada | Andalusia | Spain |
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| Hospital Universitario Regional de Málaga | Recruiting | Málaga | Andalusia | Spain |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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| Parc Taulí | Recruiting | Sabadell | Barcelona | Spain |
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| Hospital Universitario Araba Txagorritxu Victoria | Recruiting | Vitoria-Gasteiz | Basque Country | Spain |
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| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Cantabria | Spain |
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| Hospital Universitario de Burgos | Recruiting | Burgos | Castille and León | Spain |
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| Complejo Asistencial Universitario de Salamanca | Recruiting | Salamanca | Castille and León | Spain |
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| Hospital Universitario Río Hortega | Recruiting | Valladolid | Castille and León | Spain |
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| Hospital General de Ciudad Real | Recruiting | Ciudad Real | Castille-La Mancha | Spain |
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| Instituto Catalán de Oncología Badalona | Recruiting | Badalona | Catalonia | Spain |
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| Hospital de la Santa Creu y Sant Pau | Recruiting | Barcelona | Catalonia | Spain |
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| Hospital Universitario Quirón Dexeus | Recruiting | Barcelona | Catalonia | Spain |
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| Hospital Universitario San Pedro Alcántara | Recruiting | Cáceres | Extremadura | Spain |
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| Onkologikoa | Recruiting | Donostia / San Sebastian | Guipuzcoa | 20014 | Spain |
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| Hospital San Pedro | Recruiting | Logroño | La Rioja | 26006 | Spain |
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| Hospital Lucus Augusti | Recruiting | Lugo | Lugo | 27003 | Spain |
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| Hospital Universitario La Princesa | Recruiting | Madrid | Madrid | 28006 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | Madrid | Spain |
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| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Madrid | Spain |
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| Hospital Universitario Puerta de Hierro-Majadahonda | Recruiting | Majadahonda | Madrid | Spain |
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| Hospital Clínico Universitario Virgen de la Arrixaca | Recruiting | El Palmar | Murcia | 30120 | Spain |
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| Hospital Costa del Sol | Recruiting | Marbella | Málaga | Spain |
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| Complejo Hospitalario de Navarra | Recruiting | Pamplona | Navarre | Spain |
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| Hospital Universitario Son Llàtzer | Recruiting | Palma de Mallorca | Palma | 07198 | Spain |
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| Complejo Hospitalario de Pontevedra | Recruiting | Pontevedra | Pontevedra | 36164 | Spain |
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| Hospital Universitario de Valme | Recruiting | Seville | Sevilla | Spain |
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| Hospital Virgen de la Salud | Recruiting | Toledo | Toledo | 45004 | Spain |
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| Hospital La Ribera | Recruiting | Alzira | Valencia | 46600 | Spain |
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| Hospital General Universitario de Valencia | Recruiting | Valencia | Valencia | Spain |
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| Instituto Valenciano de Oncología | Not yet recruiting | Valencia | Valencia | Spain |
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| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | Valladolid | 47003 | Spain |
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| Hospital Universitario Miguel Servet | Recruiting | Zaragoza | Zaragoza | 500009 | Spain |
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| Hospital Clínico Universitario Lozano Blesa | Recruiting | Zaragoza | Zaragoza | 50009 | Spain |
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| Hospital Clínico San Carlos | Recruiting | Madrid | 28040 | Spain |
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| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | Spain |
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| Clínica Universidad de Navarra | Recruiting | Pamplona | Spain |
|
| Derived |
| Espinosa E, Berciano-Guerrero MA, Munoz-Couselo E, Puertolas T, Manzano JL, Soria A, de Miguel PA, Crespo G, Sanz LG, Cerezuela-Fuentes P, de la Rosa CA, Majem M, Castano AG, Berrocal A, Arroyo FRG, de la Borbolla MR, Bellido L, Martinez JM, Fernandez LA, Carnicero AM, Castro RL, Rodriguez AB, Lecumberri MJ, Guzman JCV, Balea BC, Rodriguez JF, Bautista JV, Perez VN, Mujika K, Subias MC, Hernandez B, Algarra SM, Marquez-Rodas I. Response rate and long-term survival in patients with advanced melanoma: data from the prospective cohort study gem-1801. Clin Transl Oncol. 2026 May;28(5):1807-1814. doi: 10.1007/s12094-025-04098-3. Epub 2025 Nov 28. |
| 40715648 | Derived | Ayala-de Miguel P, Munoz-Couselo E, Gutierrez-Sanz L, Fernandez LA, Navarro-Perez V, Berciano-Guerrero MA, Garcia-Arroyo F, Aguado-de la Rosa C, Cerezuela-Fuentes P, Majem M, Campos-Balea B, Soria A, Hernandez-Marin B, Garcia-Castano A, Martin-Algarra S, Marquez-Rodas I. Retreatment and rechallenge with BRAF/MEK inhibitors in patients with metastatic melanoma: results from the real-world Spanish Melanoma Registry (GEM-1801). Clin Transl Oncol. 2026 Jan;28(1):320-329. doi: 10.1007/s12094-025-04005-w. Epub 2025 Jul 27. |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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