Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage

May 29, 2019 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service D'Orl Et de Chirurgie Cervico-Faciale
        • Contact:
        • Sub-Investigator:
          • Guillaume TRAU, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

May 31, 2019

Last Update Submitted That Met QC Criteria

May 29, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7417

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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