Location of Lower Limb Cutaneous Melanomas as a Prognosti... | NCT04625491

Studies
Location of Lower Limb Cutaneous Melanomas as a Prognostic Factor.

NCT04625491

Sponsor

Hospital Universitario Virgen de la Arrixaca

Status

Unknown status

Last Update Posted

Feb 10, 2021Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Cutaneous Melanoma
Anatomical Pathological Condition

Interventions

Observational

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2000Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Nov 6, 2020

First Submission Date that Met QC Criteria

Nov 6, 2020

First Posted Date

Nov 12, 2020Actual

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

Feb 9, 2021

Last Update Posted Date

Feb 10, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antonio Pinero-Madrona, Specialist in Surgery, MD PhD, Hospital Universitario Virgen de la ArrixacaPrincipal Investigator

Lead Sponsor

Hospital Universitario Virgen de la ArrixacaOTHER

Collaborators

Not provided

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

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

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.

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

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Location on lower limb		Proximal (thigh) Medium (leg) Distal (ankle and foot)	Other: Observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Observational	Location on lower limb

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cutaneous melanoma on the lower limb

Exclusion Criteria:

Incomplete staging

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

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Antonio Piñero-Madrona, MD PhD	Contact	+34 968369500	9677	pineromadrona@gmail.com

Overall Officials

Name	Affiliation	Role
Antonio Piñero-Madrona, MD PhD	Associate Professor of Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario "Virgen de la Arrixaca"	Recruiting	Murcia		30120	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36862181	Derived	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.

ID	Term
D008545	Melanoma
D020763	Pathological Conditions, Anatomical

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

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration