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出境医 / 临床实验 / Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage
Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage
Study Description
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.
| Condition or disease |
|---|
| Neuroma, Acoustic |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 40 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage |
| Actual Study Start Date : | May 29, 2019 |
| Estimated Primary Completion Date : | May 2020 |
| Estimated Study Completion Date : | May 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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 ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
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)
Contacts and Locations
Contacts
| Contact: Anne CHARPIOT, MD, PhD | 33 3 88 12 76 49 | anne.charpiot@chru-strasbourg.fr | |
| Contact: Guillaume TRAU, MD | 33 3 88 12 76 49 | Guillaume.trau@chru-strasbourg.fr |
Locations
| France | |
| Service D'Orl Et de Chirurgie Cervico-Faciale | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Anne CHARPIOT, MD, PhD 33 3 88 12 76 49 anne.charpiot@chru-strasbourg.fr | |
| Contact: Guillaume TRAU, MD 33 3 88 12 76 49 Guillaume.trau@chru-strasbourg.fr | |
| Principal Investigator: Anne CHARPIOT, MD, PhD | |
| Sub-Investigator: Guillaume TRAU, MD | |
Sponsors and Collaborators
University Hospital, Strasbourg, France
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 29, 2019 | ||||
| First Posted Date | May 31, 2019 | ||||
| Last Update Posted Date | May 31, 2019 | ||||
| Actual Study Start Date | May 29, 2019 | ||||
| Estimated Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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 ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage | ||||
| Official Title | Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage | ||||
| 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 | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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 | ||||
| Condition | Neuroma, Acoustic | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
40 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | May 2020 | ||||
| Estimated Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03970681 | ||||
| Other Study ID Numbers | 7417 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | University Hospital, Strasbourg, France | ||||
| Study Sponsor | University Hospital, Strasbourg, France | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | University Hospital, Strasbourg, France | ||||
| Verification Date | May 2019 | ||||
