Neuroma, AcousticNCT03970681
Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage
An observational study of Neuroma, Acoustic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroma, Acoustic
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2019to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject followed in radiology for the assessment or follow-up of neuroma between January 01, 2013 and June 30, 2018
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service D'Orl Et de Chirurgie Cervico-Faciale
Strasbourg, 67091
Anne CHARPIOT, MD, PhD, 33 3 88 12 76 49, anne.charpiot@chru-strasbourg.fr
Guillaume TRAU, MD, 33 3 88 12 76 49, Guillaume.trau@chru-strasbourg.fr
About this study
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.
- Conditions
- Neuroma, Acoustic
- Keywords
- Acoustic neuroma, Vestibular schwannoma, Spontaneous shrinkage, Neoplasm regression, Volume quantification, Tridimensional measurements, Volumetric measurements
- Medical subject headings
- Neuroma, Acoustic
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of tumoral volume using tridimensional reconstruction on MRI, and kinetics of decay
Measured: Files analyzed from January 01, 2013 to June 30, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start29 May 2019
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroma, AcousticStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970681
- Sponsor's protocol ID
- 7417
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage
- ClinicalTrials.gov ID
- NCT03970681
- Acronym / sponsor ID
- 7417
- Conditions
- Neuroma, Acoustic
- Keywords
- Acoustic neuroma, Vestibular schwannoma, Spontaneous shrinkage, Neoplasm regression, Volume quantification, Tridimensional measurements, Volumetric measurements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject followed in radiology for the assessment or follow-up of neuroma between January 01, 2013 and June 30, 2018
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroma, Acoustic, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne CHARPIOT, MD, PhD (33 3 88 12 76 49, anne.charpiot@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.