Observational Study of a Cohort of Patients With Heredita... | NCT04217538

Studies
Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa

NCT04217538

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Jan 3, 2020Actual

Enrollment

41Actual

Phase

Not provided

Conditions

Epidermolysis Bullosa

Interventions

clinical exam

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

Dec 2019

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 4, 2017Actual

Primary Completion Date

Dec 11, 2019Actual

Completion Date

Dec 11, 2019Actual

First Submitted Date

Dec 31, 2019

First Submission Date that Met QC Criteria

Jan 2, 2020

First Posted Date

Jan 3, 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

Jan 2, 2020

Last Update Posted Date

Jan 3, 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

Hereditary Epidermolysis Bullosa (EBH) are rare dermatologic diseases characterized by cutaneous and mucosa fragility. Oral manifestations of few small cohort have been published. The main objective of this multicentric cohort study first in Europe was to report the oral status of these patients that were consulted in the MRDRC of this disease in Nice (France), Toulouse (France) and Louvain (Belgium). Then a correlation between the oral characteristics and the EBH type will be made, in order to facilitate the management of patient care and the prevention program that can be established to improve their oral health.

Detailed Description

Not provided

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

41Actual

Label	Type	Description	Intervention Names
EBH			Other: clinical exam

Name	Type	Description	Arm Group Labels	Other Names
clinical exam	Other	clinical oral examination	EBH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dental structural abnormalities and/or caries	number of defect /dental caries dor each toth	1 day

Secondary Outcomes

Measure	Description	Time Frame
gingival biotype	clinical observation of gingiva (thin or thick)	1 day
gingival status	observation and classification of the gingiva (healthy, inflammed or hyperplastic)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient with EBH
patient consent for examination and use the clinical data for publication purpose

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Months

Maximum Age

78 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with EBH are recruted from the 2 MRDRC of the disease in France and the one of Belgium, the dental visit was/is organized for each visit/follow up of the patient in the center (annual or bianual visit)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nice Hospital		Nice		06000	France
Toulouse University

Condition Browse Module

MeSH Terms

ID	Term
D004820	Epidermolysis Bullosa

Ancestor Terms

ID	Term
D012868	Skin Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012873	Skin Diseases, Genetic

Browse Leaves

Not provided

Browse Branches

Not provided