Location of Lower Limb Cutaneous Melanomas as a Prognostic Factor.

February 9, 2021 updated by: Antonio Pinero-Madrona, Hospital Universitario Virgen de la Arrixaca

Lower Limb Cutaneous Melanoma: Observational Prognostic Study About Specific Location of the Primary Lesion.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ambispective (retrospective and prospective) observational register of patients with cutaneous melanoma on lower limbs are grouped in 1) proximal (thigh), 2) medium (leg), and 3) distal (ankle and foot) location. Analysis of melanoma-specific overall and disease-free survival will be made, as well as multivariant analysis for prognostic variables including anatomical location.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario "Virgen de la Arrixaca"
        • Contact:
        • Principal Investigator:
          • Antonio Piñero, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Cutaneous melanoma on the lower limb

Exclusion Criteria:

  • Incomplete staging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Location on lower limb
Proximal (thigh) Medium (leg) Distal (ankle and foot)
Other: Observational
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melanoma-specific overall survival
Time Frame: Ten years
Melanoma-specific overall survival
Ten years
Melanoma-specific disease-free survival
Time Frame: Ten years
Melanoma-specific disease-free survival
Ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Investigators

  • Principal Investigator: Antonio Piñero-Madrona, MD PhD, Associate Professor of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-4-2-HUVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

An interim analysis of data is planned in 2020.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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