Clinical and Radiological Evaluation of Acoustic Neuromas... | NCT03970681

Studies
Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage

NCT03970681

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

May 31, 2019Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Neuroma, Acoustic

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

May 2019

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

May 29, 2019Actual

Primary Completion Date

May 2020Estimated

Completion Date

May 2020Estimated

First Submitted Date

May 29, 2019

First Submission Date that Met QC Criteria

May 29, 2019

First Posted Date

May 31, 2019Actual

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

May 29, 2019

Last Update Posted Date

May 31, 2019Actual

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

To evaluate the regression characteristics of this Acoustic Neuroma population using volumetric data To study the relationship between regression and clinical characteristics including tinnitus, dizziness, hearing loss, and the intrinsic characteristics of the patients.

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

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of tumoral volume using tridimensional reconstruction on MRI, and kinetics of decay		Files analyzed from January 01, 2013 to June 30, 2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major subject (≥18 years old)
Subject followed in radiology for the assessment or follow-up of neuroma between January 01, 2013 and June 30, 2018
Subject who has agreed to the use of his data for the purpose of this research
Subject presenting an untreated neuroma

Exclusion Criteria:

Subject having expressed his opposition to participating in the study
Subject followed for neuroma of other cranial pairs,
Subject followed in the context of type II neurofibromatosis
Subject with a treated neuroma (radiotherapy or surgery)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subject followed in radiology for the assessment or follow-up of neuroma between January 01, 2013 and June 30, 2018

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne CHARPIOT, MD, PhD	Contact	33 3 88 12 76 49		anne.charpiot@chru-strasbourg.fr
Guillaume TRAU, MD	Contact	33 3 88 12 76 49		Guillaume.trau@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service D'Orl Et de Chirurgie Cervico-Faciale	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D009464	Neuroma, Acoustic

Ancestor Terms

ID	Term
D009442	Neurilemmoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided