Development Cellular Models of the Ear and Nose to Study... | NCT04823195

Studies
Development Cellular Models of the Ear and Nose to Study the Mechanisms of Hearing

NCT04823195

Sponsor

University Hospital, Brest

Status

Unknown status

Last Update Posted

Sep 18, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Hearing Loss, GJB2, Cis Regulation, DFNB1

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

Sep 2023

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

Jun 15, 2021Actual

Primary Completion Date

Jun 15, 2024Estimated

Completion Date

Jun 15, 2024Estimated

First Submitted Date

Mar 29, 2021

First Submission Date that Met QC Criteria

Mar 29, 2021

First Posted Date

Mar 30, 2021Actual

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

Sep 15, 2023

Last Update Posted Date

Sep 18, 2023Actual

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

Development of cells culturesissued from Nose and Ear to study auditory mecanisms.

Study of the cis-Modulation of the gene GJB2 for the patients with early presbycusis to identify the genetic cause of hearing loss.

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

Retention

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
GJB2 cis regulation	Culture cell model	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hearing loss Presbycusis Exostosis

Exclusion Criteria:

Genetic hearing loss

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

over 18 years old full consent With exostosis, or having cochlear implant surgery, or early presbycusis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rémi Marianowski	Contact	02-98-22-33-78		remi.marianowski@chu-brest.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest	Recruiting	Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available beginning two years and ending five years following the publication

Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D034381	Hearing Loss

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders

Browse Leaves

Not provided

Browse Branches

Not provided