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Melanoma Stage IvGEM-1801NCT03605771

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

An observational study of Melanoma Stage Iv and Melanoma Stage Iii, run by Grupo Español Multidisciplinar de Melanoma at 39 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Daily Clinical Practice
How many people
400 participants
Where
39 sitesSpain
Study dates
7 Aug 2018to Dec 2027
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Any patient not complying with inclusion criteria.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Spain39 sites

  • Hospital Virgen de los Lirios

    Alcoy, Alicante, 03804

  • Hospital La Ribera

    Alzira, Valencia, 46600

  • Instituto Catalán de Oncología Badalona

    Badalona, Catalonia

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Hospital de la Santa Creu y Sant Pau

    Barcelona, Catalonia

  • Hospital Universitario Quirón Dexeus

    Barcelona, Catalonia

  • Hospital Universitario de Burgos

    Burgos, Castille and León

  • Hospital Universitario San Pedro Alcántara

    Cáceres, Extremadura

  • Hospital General de Ciudad Real

    Ciudad Real, Castille-La Mancha

  • Onkologikoa

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia

  • Onconogranada

    Granada, Andalusia

  • Hospital San Pedro

    Logroño, La Rioja, 26006

  • Hospital Lucus Augusti

    Lugo, Lugo, 27003

  • Hospital Universitario La Princesa

    Madrid, Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, Madrid

  • Hospital Universitario Regional de Málaga

    Málaga, Andalusia

  • Hospital Costa del Sol

    Marbella, Málaga

  • Hospital Universitario Son Llàtzer

    Palma de Mallorca, Palma, 07198

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre

  • Clínica Universidad de Navarra

    Pamplona

  • Complejo Hospitalario de Pontevedra

    Pontevedra, Pontevedra, 36164

  • Parc Taulí

    Sabadell, Barcelona

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, Castille and León

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria

  • Hospital Universitario de Valme

    Seville, Sevilla

  • Hospital Virgen de la Salud

    Toledo, Toledo, 45004

  • Hospital General Universitario de Valencia

    Valencia, Valencia

  • Instituto Valenciano de Oncología

    Valencia, Valencia

  • Hospital Universitario Río Hortega

    Valladolid, Castille and León

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid, 47003

  • Hospital Universitario Araba Txagorritxu Victoria

    Vitoria-Gasteiz, Basque Country

  • Hospital Universitario Miguel Servet

    Zaragoza, Zaragoza, 500009

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

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.

Being tested
Daily Clinical Practice
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daily Clinical PracticeOther

    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.

Study groups in NCT03605771
Study groupRoleWhat they receive
Advanced MelanomaPatients 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.
Receives: Other: Daily Clinical Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sample Characteristics

    Sociodemographic and disease characteristics of patients diagnosed with stage III, metastatic or unresectable melanoma at first diagnosis.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2018
  2. Study start7 Aug 2018
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03605771
Sponsor's protocol ID
GEM-1801
Acronym
GEM-1801
Status last verified
Sep 2026
First submitted
20 Jul 2018
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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. 2026 Jun;28(6):2377-2385. doi: 10.1007/s12094-025-04164-w. Epub 2025 Dec 20.

    PubMed 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 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. 2026 May;28(5):1807-1814. doi: 10.1007/s12094-025-04098-3. Epub 2025 Nov 28.

    PubMed 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 Melanoma Registry (GEM-1801). Clin Transl Oncol. 2026 Jan;28(1):320-329. doi: 10.1007/s12094-025-04005-w. Epub 2025 Jul 27.

    PubMed 40715648

Questions about this trial

What is this clinical trial studying?

An observational study of Melanoma Stage Iv and Melanoma Stage Iii, run by Grupo Español Multidisciplinar de Melanoma at 39 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sample Characteristics (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03605771, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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