Evolution of Cochleovestibular Schwannomas

NCT ID: NCT04417868

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Investigators want to know the natural history of the vestibular schwannomas: increasing, decreasing or stability, by monitoring more than 3 MRIs during a span of more than 2 years. They will obtain 3 groups: the volume increasing schwannomas which will be the most important group, the schwannomas that will be stable and a small group where the schwannomas will decrease.

The secondary purpose is that the investigators want to know the threshold values: a minimum volume under which we are sure that the schwannoma will not increase, a maximum value where it will increase and if its evolution can be correlated to clinical or radiological criteria.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schwannoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age over 18 years
* having a typical vestibular schwannoma diagnosis during the first MRI, having a minimum of 3 internal auditory canal MRIs on the same machine (Signa HDxt, General Electric, Strasbourg, France) ) at the Hôpitaux Universitaires de Strasbourg
* patients consenting to participate

Exclusion Criteria

* intra-labyrinthical extension
* treatment before the 3 MRIs
* no injection of gadolinium
* atypical diagnosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service Imagerie 1

Srtrasbourg, Strasbourg, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aïna VENKATASAMY, MD

Role: CONTACT

33 3 88 12 78 65

Saïd CHAYER, PhD, HDR

Role: CONTACT

33 3 88 11 66 90

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aïna VENKATASAMY, MD

Role: primary

33 3 88 12 78 65

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7560

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vestibular Schwannoma Organoids
NCT05786144 COMPLETED