NCT03970681

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

11 months

First QC Date

May 29, 2019

Last Update Submit

May 29, 2019

Conditions

Keywords

Acoustic neuromaVestibular schwannomaSpontaneous shrinkageNeoplasm regressionVolume quantificationTridimensional measurementsVolumetric measurements

Outcome Measures

Primary Outcomes (1)

  • Measurement of tumoral volume using tridimensional reconstruction on MRI, and kinetics of decay

    Files analyzed from January 01, 2013 to June 30, 2018

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service D'Orl Et de Chirurgie Cervico-Faciale

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

May 29, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 31, 2019

Record last verified: 2019-05

Locations