Congenital Naevi of Lower Limb in the Child | NCT04297579

Studies
Congenital Naevi of Lower Limb in the Child

NCT04297579

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Jun 5, 2020Actual

Enrollment

176Actual

Phase

Not provided

Conditions

Congenital Melanocytar Nevi in the Lower Limb

Interventions

Not provided

Countries

France

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1984Actual

Primary Completion Date

Apr 1, 2020Actual

Completion Date

May 1, 2020Actual

First Submitted Date

Mar 3, 2020

First Submission Date that Met QC Criteria

Mar 3, 2020

First Posted Date

Mar 5, 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

Jun 4, 2020

Last Update Posted Date

Jun 5, 2020Actual

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

Depending on its dimensions, it is difficult to predict if a congenital nevi of the lower limb can be surgically removed by a unique simple procedure or by a complex procedure (expander, skin graft etc..), with a good result.

This study retrospectively reviewed the practice of our team of surgeons depending on the size of the naevus to reveal a dimension threshold that can be used in the future to help to choose between a simple or a complex procedure.

Detailed Description

Retrospective study using medical file data only. No intervention nor phone call etc.. to the patients or their parents.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

176Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nevi Estimated Size	Nevi Estimated Size (centimeters)	within three weeks after surgery

Secondary Outcomes

Measure	Description	Time Frame
post-operative complications depending on the initial size of the naevus	post-operative complications depending on the initial size of the naevus : percentage of complication rate	assessed within 6 months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

- Child + congenital nevi in the lower limb + had removal surgery

Exclusion criteria:

- More than one congenital nevi in the lower limb.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children that had congenital nevi surgery removal, in the lower limb.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillaume CAPTIER, MD.PhD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009506	Nevus

Ancestor Terms

ID	Term
D018326	Nevi and Melanomas
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided