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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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 Marañon
        • 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 Ramón 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 Clínico 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 Clínico 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 Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo Español Multidisciplinar de Melanoma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Iván Márquez Rodas, M.D., Hospital General Universitario Gregorio Marañon
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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