Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Sample Characteristics [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Patients of legal age with stage III, metastatic, or unresectable melanoma at first diagnosis after January 8, 2018. First diagnosis is understood as: a. Disease onset as metastatic or unresectable disease; b. 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.
• Signing the Informed Consent Form (ICF).
• A patient may have received the first or subsequent treatments for metastatic or unresectable disease in a hospital other than the centre where the ICF was signed, as long as the patient meets the inclusion criteria 1.
• 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.

Критерии исключения

• Any patient not complying with inclusion criteria.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 39 центров

• Hospital Virgen de los Lirios — Alcoy
• Hospital Universitario Virgen de las Nieves — Granada
• Onconogranada — Granada
• Hospital Universitario Regional de Málaga — Málaga
• Hospital Universitari Vall d'Hebron — Barcelona
• Parc Taulí — Sabadell
• Hospital Universitario Araba Txagorritxu Victoria — Vitoria-Gasteiz
• Hospital Universitario Marqués de Valdecilla — Santander
• … и ещё 31 центр

Публикации

• 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 PMID 41420791
• 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 PMID 41313559
• 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 M PMID 40715648

Идентификаторы

NCT: NCT03605771 · GEM-1801

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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