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

Sponsor

Grupo Español Multidisciplinar de Melanoma (Other)

Overall Status

Recruiting

CT.gov ID

NCT03605771

Collaborator

(none)

400

Enrollment

Locations

48.8

Anticipated Duration (Months)

10.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Stage Iv Melanoma Stage Iii Advanced Cancer	Other: Daily Clinical Practice

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 7, 2018

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	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: Disease onset as metastatic or unresectable disease. 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.

Arm

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: Disease onset as metastatic or unresectable disease. 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.

Outcome Measures

Primary Outcome Measures

Sample Characteristics [Baseline]
Sociodemographic and disease characteristics of patients diagnosed with stage III, metastatic or unresectable melanoma at first diagnosis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Virgen de los Lirios	Alcoy	Alicante	Spain	03804
2	Hospital Universitario Virgen de las Nieves	Granada	Andalucía	Spain
3	Onconogranada	Granada	Andalucía	Spain
4	Hospital Universitario Regional de Málaga	Málaga	Andalucía	Spain
5	Parc Taulí	Sabadell	Barcelona	Spain
6	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria	Spain
7	Hospital General de Ciudad Real	Ciudad Real	Castilla - La Mancha	Spain
8	Hospital Universitario de Burgos	Burgos	Castilla Y León	Spain
9	Complejo Asistencial Universitario de Salamanca	Salamanca	Castilla Y León	Spain
10	Hospital Universitario Río Hortega	Valladolid	Castilla Y León	Spain
11	Instituto Catalán de Oncología Badalona	Badalona	Cataluña	Spain
12	Hospital de la Santa Creu y Sant Pau	Barcelona	Cataluña	Spain
13	Hospital Universitario Quirón Dexeus	Barcelona	Cataluña	Spain
14	Hospital General Universitario de Valencia	Valencia	Comunidad Valenciana	Spain
15	Instituto Valenciano de Oncología	Valencia	Comunidad Valenciana	Spain
16	Hospital Universitario San Pedro Alcántara	Cáceres	Extremadura	Spain
17	Onkologikoa	Donostia	Guipuzcoa	Spain	20014
18	Hospital San Pedro	Logroño	La Rioja	Spain	26006
19	Hospital Universitario Puerta de Hierro-Majadahonda	Majadahonda	Madrid	Spain
20	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia	Spain	30120
21	Hospital Costa del Sol	Marbella	Málaga	Spain
22	Complejo Hospitalario de Navarra	Pamplona	Navarra	Spain
23	Hospital Universitario Son Llàtzer	Palma De Mallorca	Palma	Spain	07198
24	Hospital Universitario Araba Txagorritxu Victoria	Vitoria Gasteiz	País Vasco	Spain
25	Hospital La Ribera	Alcira	Valencia	Spain	46600
26	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
27	Hospital Lucus Augusti	Lugo		Spain	27003
28	Hospital Universitario La Princesa	Madrid		Spain	28006
29	Hospital Clínico San Carlos	Madrid		Spain	28040
30	Hospital General Universitario Gregorio Marañón	Madrid		Spain
31	Hospital Universitario La Paz	Madrid		Spain
32	Hospital Universitario Ramón y Cajal	Madrid		Spain
33	Clínica Universidad de Navarra	Pamplona		Spain
34	Complejo Hospitalario de Pontevedra	Pontevedra		Spain	36164
35	Hospital Universitario de Valme	Sevilla		Spain
36	Hospital Virgen de la Salud	Toledo		Spain	45004
37	Hospital Clínico Universitario de Valladolid	Valladolid		Spain	47003
38	Hospital Universitario Miguel Servet	Zaragoza		Spain	500009
39	Hospital Clínico Universitario Lozano Blesa	Zaragoza		Spain	50009

Sponsors and Collaborators

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., Clínica Universidad de Navarra

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Grupo Español Multidisciplinar de Melanoma

ClinicalTrials.gov Identifier:

NCT03605771

Other Study ID Numbers:

GEM-1801

First Posted:

Jul 30, 2018

Last Update Posted:

Mar 10, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Mar 10, 2022