NCT04625491

Brief Summary

Observational study to know the relevance of specific anatomical location of cutaneous melanoma on lower limbs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2000

Completed
20.9 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

21.9 years

First QC Date

November 6, 2020

Last Update Submit

February 9, 2021

Conditions

Keywords

cutaneous melanomalower limbprognostic

Outcome Measures

Primary Outcomes (2)

  • Melanoma-specific overall survival

    Melanoma-specific overall survival

    Ten years

  • Melanoma-specific disease-free survival

    Melanoma-specific disease-free survival

    Ten years

Study Arms (1)

Location on lower limb

Proximal (thigh) Medium (leg) Distal (ankle and foot)

Other: Observational

Interventions

Observational

Location on lower limb

Eligibility Criteria

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

Patients that were cared of cutaneous melanoma on the lower limb.

You may qualify if:

  • Cutaneous melanoma on the lower limb

You may not qualify if:

  • Incomplete staging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario "Virgen de la Arrixaca"

Murcia, 30120, Spain

RECRUITING

Related Publications (1)

  • Pinero-Madrona A, Cerezuela-Fuentes P, Ruiz-Merino G, Martinez-Barba E, Ortiz-Reina S, Martinez-Ortiz MJ, Lopez-Avila A, Frias-Iniesta JF, Viney A, Cabezas-Herrera J. Lower limb cutaneous melanoma surgery: location matters. Arch Dermatol Res. 2023 Sep;315(7):1971-1978. doi: 10.1007/s00403-023-02571-z. Epub 2023 Mar 2.

MeSH Terms

Conditions

MelanomaPathological Conditions, Anatomical

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Antonio Piñero-Madrona, MD PhD

    Associate Professor of Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Piñero-Madrona, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Surgery, MD PhD

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

January 1, 2000

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

An interim analysis of data is planned in 2020.

Locations