NCT05673681

Brief Summary

The goal of this patient registry is to describe risk factors for bad prognosis of melanoma in Spain. The main questions it aims to answer are:

  • To describe socioeconomical individual risk factors associated with melanoma prognosis, such as gender, residence area or socioeconomic level.
  • To describe potentially modifiable characteristics of health care associated with prognosis, such as waiting times, type of centre that makes the diagnosis or use of teledermatology Participants data will be gathered for analysis, without any change in the way that they are being treated.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
74mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Jun 2022Jun 2032

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

10 years

First QC Date

January 2, 2023

Last Update Submit

January 5, 2023

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

  • AJCC (American Joint Committee on Cancer) TNM stage (Tumor, node, metastasis)

    Staging based on tumor thickness and ulceration, spread to lymph nodes and spread to distant sites.

    1 day At diagnosis

  • Breslow thickness

    Breslow thickness is the measurement of the depth of the melanoma from the surface of your skin down through to the deepest point of the tumour.

    1 day At diagnosis

Secondary Outcomes (2)

  • Time to progression

    through study completion, an average of 3 years

  • Survival

    through study completion, an average of 3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive patients with a diagnosis of invasive primary cutaneous melanoma in participating centres.

You may qualify if:

  • All consecutive patients with a diagnosis of invasive primary cutaneous melanoma in participating centres.

You may not qualify if:

  • In-situ melanomas
  • non-cutaneous melanomas,
  • metastatic melanoma with unknown primary site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

RECRUITING

Complexo Hospitalario Universitario de A Coruña

A Coruña, Spain

NOT YET RECRUITING

Hospital Clinic

Barcelona, Spain

RECRUITING

Hospital San Juan de Dios

Córdoba, Spain

RECRUITING

Hospital Universitario de Gran Canaria Dr Negrín

Las Palmas, Spain

RECRUITING

Complejo Asistencial Universitario de León

León, Spain

RECRUITING

Clínica Dermatológica Internacional

Madrid, Spain

NOT YET RECRUITING

Clínica Universitaria de Navarra ( sede de Madrid)

Madrid, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital La Paz

Madrid, Spain

RECRUITING

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

NOT YET RECRUITING

Ruber Internacional

Madrid, Spain

NOT YET RECRUITING

Hospital Central de Asturias

Oviedo, Spain

RECRUITING

Hospital Son LLàtzer

Palma de Mallorca, Spain

RECRUITING

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

NOT YET RECRUITING

H.U. Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Spain

RECRUITING

Hospital Universitario Virgen Macarena de Sevilla

Seville, Spain

RECRUITING

Quirón Salud Sevilla

Seville, Spain

NOT YET RECRUITING

Hospital La Fé

Valencia, Spain

NOT YET RECRUITING

Instituto Valenciano de Oncología

Valencia, Spain

RECRUITING

Hospital Miguel Servet

Zaragoza, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Mercè Grau, MD

CONTACT

34 91 544 62 84merce.grau@equipo.aedv.es

Ignacio Garcia-Doval, PhD

CONTACT

ignacio.garcia.doval@equipo.aedv.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 6, 2023

Study Start

June 1, 2022

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

June 1, 2032

Last Updated

January 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(21)