Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain
GEM-1801
1 other identifier
observational
400
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Longer than P75 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 30, 2018
CompletedStudy Start
First participant enrolled
August 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 4, 2025
April 1, 2025
7.3 years
July 20, 2018
April 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Sample Characteristics
Sociodemographic and disease characteristics of patients diagnosed with stage III, metastatic or unresectable melanoma at first diagnosis.
Baseline
Study Arms (1)
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.
Interventions
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
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.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Hospital Virgen de los Lirios
Alcoy, Alicante, 03804, 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, 08035, 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, 20014, Spain
Hospital San Pedro
Logroño, La Rioja, 26006, Spain
Hospital Lucus Augusti
Lugo, Lugo, 27003, Spain
Hospital Universitario La Princesa
Madrid, Madrid, 28006, 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, 30120, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Son Llàtzer
Palma de Mallorca, Palma, 07198, Spain
Complejo Hospitalario de Pontevedra
Pontevedra, Pontevedra, 36164, Spain
Hospital Universitario de Valme
Seville, Sevilla, Spain
Hospital Virgen de la Salud
Toledo, Toledo, 45004, Spain
Hospital La Ribera
Alzira, Valencia, 46600, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Instituto Valenciano de Oncología
Valencia, Valencia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003, Spain
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 500009, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, 50009, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Related Publications (3)
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. 2025 Dec 20. doi: 10.1007/s12094-025-04164-w. Online ahead of print.
PMID: 41420791DERIVEDEspinosa 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. 2025 Nov 28. doi: 10.1007/s12094-025-04098-3. Online ahead of print.
PMID: 41313559DERIVEDAyala-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.
PMID: 40715648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Iván Márquez Rodas, M.D.
Hospital General Universitario Gregorio Marañón
- PRINCIPAL INVESTIGATOR
Salvador Martín Algarra, M.D.
Clínica Universidad de Navarra
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2018
First Posted
July 30, 2018
Study Start
August 7, 2018
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
April 4, 2025
Record last verified: 2025-04