Descriptive Observational Study on the Characteristics of Advanced and Metastatic Melanoma in Spain (GEM-1801)

April 2, 2025 updated by: Grupo Español Multidisciplinar de Melanoma
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Responsible person designated by the sponsor
  • Phone Number: +34 93 434 44 12
  • Email: investigacion@mfar.net

Study Contact Backup

  • Name: A Responsible Person Designated by the Sponsor
  • Phone Number: +34 93 434 44 12
  • Email: investigacion@mfar.net

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Lugo, Spain, 27003
        • Recruiting
        • Hospital Lucus Augusti
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario La Princesa
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Marañón
        • Contact:
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Pontevedra, Spain, 36164
        • Recruiting
        • Complejo Hospitalario de Pontevedra
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario de Valme
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Toledo, Spain, 45004
        • Recruiting
        • Hospital Virgen de la Salud
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Zaragoza, Spain, 500009
        • Recruiting
        • Hospital Universitario Miguel Servet
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Alicante
      • Alcoy, Alicante, Spain, 03804
        • Recruiting
        • Hospital Virgen de los Lirios
        • Contact:
          • Pé
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Andalucía
      • Granada, Andalucía, Spain
        • Recruiting
        • Hospital Universitario Virgen De Las Nieves
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Granada, Andalucía, Spain
        • Not yet recruiting
        • Onconogranada
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Málaga, Andalucía, Spain
        • Recruiting
        • Hospital Universitario Regional de Malaga
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Barcelona
      • Sabadell, Barcelona, Spain
        • Recruiting
        • PARC Tauli
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Cantabria
      • Santander, Cantabria, Spain
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Castilla - La Mancha
      • Ciudad Real, Castilla - La Mancha, Spain
        • Recruiting
        • Hospital General de Ciudad Real
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Castilla y León
      • Burgos, Castilla y León, Spain
        • Recruiting
        • Hospital Universitario de Burgos
        • Contact:
          • I.
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Salamanca, Castilla y León, Spain
        • Recruiting
        • Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Valladolid, Castilla y León, Spain
        • Recruiting
        • Hospital Universitario Rio Hortega
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Cataluña
      • Badalona, Cataluña, Spain
        • Recruiting
        • Instituto Catalán de Oncología Badalona
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Barcelona, Cataluña, Spain
        • Recruiting
        • Hospital de La Santa Creu Y Sant Pau
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Barcelona, Cataluña, Spain
        • Recruiting
        • Hospital Universitario Quiron Dexeus
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Recruiting
        • Hospital General Universitario de Valencia
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
      • Valencia, Comunidad Valenciana, Spain
        • Not yet recruiting
        • Instituto Valenciano de Oncologia
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Extremadura
      • Cáceres, Extremadura, Spain
        • Recruiting
        • Hospital Universitario San Pedro Alcántara
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Guipuzcoa
      • Donostia, Guipuzcoa, Spain, 20014
        • Recruiting
        • Onkologikoa
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
    • Madrid
      • Majadahonda, Madrid, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro-Majadahonda
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clinico Universitario Virgen de La Arrixaca
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Málaga
      • Marbella, Málaga, Spain
        • Recruiting
        • Hospital Costa del Sol
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Navarra
      • Pamplona, Navarra, Spain
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
          • J.
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Palma
      • Palma De Mallorca, Palma, Spain, 07198
        • Recruiting
        • Hospital Universitario Son Llatzer
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • País Vasco
      • Vitoria Gasteiz, País Vasco, Spain
        • Recruiting
        • Hospital Universitario Araba Txagorritxu Victoria
        • Contact:
          • Principal investigator selected by the sponsor, M.D.
    • Valencia
      • Alcira, Valencia, Spain, 46600
        • Recruiting
        • Hospital La Ribera
        • Contact:
          • Principal investigator selected by the sponsor, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any patient not complying with inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sample Characteristics
Time Frame: Baseline
Sociodemographic and disease characteristics of patients diagnosed with stage III, metastatic or unresectable melanoma at first diagnosis.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español Multidisciplinar de Melanoma

Investigators

  • Study Chair: Iván Márquez Rodas, M.D., Hospital General Universitario Gregorio Marañón
  • Principal Investigator: Salvador Martín Algarra, M.D., Clinica Universidad de Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2018

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 20, 2018

First Submitted That Met QC Criteria

July 20, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM-1801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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