Location of Lower Limb Cutaneous Melanomas as a Prognostic Factor.
Sponsor
Hospital Universitario Virgen de la Arrixaca (Other)
Overall Status
Recruiting
CT.gov ID
NCT04625491
Collaborator
(none)
300
1
263
1.1
Study Details
Study Description
Brief Summary
Observational study to know the relevance of specific anatomical location of cutaneous melanoma on lower limbs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
300 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Lower Limb Cutaneous Melanoma: Observational Prognostic Study About Specific Location of the Primary Lesion.
Actual Study Start Date
:
Jan 1, 2000
Anticipated Primary Completion Date
:
Dec 1, 2021
Anticipated Study Completion Date
:
Dec 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Location on lower limb Proximal (thigh) Medium (leg) Distal (ankle and foot) |
Other: Observational
Observational
|
Outcome Measures
Primary Outcome Measures
- Melanoma-specific overall survival [Ten years]
Melanoma-specific overall survival
- Melanoma-specific disease-free survival [Ten years]
Melanoma-specific disease-free survival
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Cutaneous melanoma on the lower limb
Exclusion Criteria:
- Incomplete staging
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario "Virgen de la Arrixaca" | Murcia | Spain | 30120 |
Sponsors and Collaborators
- Hospital Universitario Virgen de la Arrixaca
Investigators
- Principal Investigator: Antonio Piñero-Madrona, MD PhD, Associate Professor of Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Antonio Pinero-Madrona,
Specialist in Surgery, MD PhD,
Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT04625491
Other Study ID Numbers:
- 2020-4-2-HUVA
First Posted:
Nov 12, 2020
Last Update Posted:
Feb 10, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Antonio Pinero-Madrona,
Specialist in Surgery, MD PhD,
Hospital Universitario Virgen de la Arrixaca
Additional relevant MeSH terms: