Spanish Academy of Dermatology and Venereology (AEDV) Mel... | NCT05673681

Studies
Spanish Academy of Dermatology and Venereology (AEDV) Melanoma Registry

NCT05673681

Sponsor

Fundación Academia Española de Dermatología

Status

Recruiting

Last Update Posted

Jan 9, 2023Actual

Enrollment

7,000Estimated

Phase

Not provided

Conditions

Melanoma

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Jun 1, 2032Estimated

Completion Date

Jun 1, 2032Estimated

First Submitted Date

Jan 2, 2023

First Submission Date that Met QC Criteria

Jan 5, 2023

First Posted Date

Jan 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2023

Last Update Posted Date

Jan 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Time to progression		through study completion, an average of 3 years
Survival		through study completion, an average of 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mercè Grau, MD	Contact	34 91 544 62 84		merce.grau@equipo.aedv.es
Ignacio Garcia-Doval, PhD	Contact			ignacio.garcia.doval@equipo.aedv.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Germans Trias i Pujol	Recruiting	Badalona	Barcelona		Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided