Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain
NCT ID: NCT03605771
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2018-08-07
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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:
1. Disease onset as metastatic or unresectable disease.
2. First metastatic or unresectable relapse in the pre-established dates (after January 8, 2018) in a patient with previous localised melanoma and completely resected on dates before the pre-inclusion period.
Daily Clinical Practice
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.
Interventions
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Daily Clinical Practice
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.
Eligibility Criteria
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Inclusion Criteria
* Signing the Informed Consent Form (ICF).
* A patient can only sign one ICF (cannot sign an ICF in two different centres).
* If a patient signs the ICF in a centre during the first-line therapy and then goes to another centre with consideration for the following lines: If the centre is associated with the GEM-1801 study, researchers will do their best to update the following lines and the patient status, introducing the new information in the centre where the ICF was initially signed. This information will be provided by the patient before contacting the principal investigator and always with prior consent of the patient, who will have previously provided the consent to contact by telephone for this purpose. If this second (or subsequent) centre is not associated with the GEM- 1801 study, this will be considered loss of follow-up, unless the patient returns to the GEM-1801 start centre, wherein the reporting physicians will do their best to update the information from other centres, always with prior patient consent, who will have previously signed the ICF; c) A patient card with the assigned code will be delivered.
18 Years
ALL
No
Sponsors
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Grupo Español Multidisciplinar de Melanoma
OTHER
Responsible Party
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Principal Investigators
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Iván Márquez Rodas, M.D.
Role: STUDY_CHAIR
Hospital General Universitario Gregorio Marañón
Salvador Martín Algarra, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clínica Universidad de Navarra
Locations
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Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Onconogranada
Granada, Andalusia, Spain
Hospital Universitario Regional de Málaga
Málaga, Andalusia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
Parc Taulí
Sabadell, Barcelona, Spain
Hospital Universitario Araba Txagorritxu Victoria
Vitoria-Gasteiz, Basque Country, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital Universitario Río Hortega
Valladolid, Castille and León, Spain
Hospital General de Ciudad Real
Ciudad Real, Castille-La Mancha, Spain
Instituto Catalán de Oncología Badalona
Badalona, Catalonia, Spain
Hospital de la Santa Creu y Sant Pau
Barcelona, Catalonia, Spain
Hospital Universitario Quirón Dexeus
Barcelona, Catalonia, Spain
Hospital Universitario San Pedro Alcántara
Cáceres, Extremadura, Spain
Onkologikoa
Donostia / San Sebastian, Guipuzcoa, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital Lucus Augusti
Lugo, Lugo, Spain
Hospital Universitario La Princesa
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Son Llàtzer
Palma de Mallorca, Palma, Spain
Complejo Hospitalario de Pontevedra
Pontevedra, Pontevedra, Spain
Hospital Universitario de Valme
Seville, Sevilla, Spain
Hospital Virgen de la Salud
Toledo, Toledo, Spain
Hospital La Ribera
Alzira, Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Instituto Valenciano de Oncología
Valencia, Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, Spain
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Pé
Role: primary
I.
Role: primary
J.
Role: primary
Role: primary
References
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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. 2025 Jul 27. doi: 10.1007/s12094-025-04005-w. Online ahead of print.
Other Identifiers
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GEM-1801
Identifier Type: -
Identifier Source: org_study_id
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