Vestibular Schwannoma Clinical Trial
— NF2Official title:
Whole Exome Sequencing (WES) of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data
NCT number | NCT03210285 |
Other study ID # | NF2Tue |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 31, 2017 |
Est. completion date | July 1, 2018 |
Verified date | July 2017 |
Source | University Hospital Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Whole exome sequencing (WES) of 50 sporadic and 50 Neurofibromatosis Type2 (NF2)-associated vestibularis schwannomas (VS) in children and young adults. The aim is to gain insight into the complete genome of the NF2 associated VS compared to sporadic VS (control group). These data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically evoked potentials) and the clinical picture as well as the tumor growth rate and general data such as sex, age, side, etc.
Status | Completed |
Enrollment | 70 |
Est. completion date | July 1, 2018 |
Est. primary completion date | April 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 99 Years |
Eligibility |
Inclusion Criteria: - Study population: Operated NF2-associated VS - Control group: Operated sporadic VS - Consent to participation in the study by the patient / legal guardian in prospective inclusion or consent to the use of stored specimens in retrospective inclusion - Age: 0 -99 years Exclusion Criteria: - Lack of informed consent - Patient's request (withdrawal of the consent statement for the evaluation of the data and further storage of the blood / tissue samples) |
Country | Name | City | State |
---|---|---|---|
Germany | University Department of Neurosurgery Tübingen | Tübingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | National Center for Tumor Diseases, Heidelberg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation clinical-volumetric pathologies and distinct genetic features | Correlation between interindividually different clinical-volumetric pathologies and distinct genetic features | Within 1 week after measurement | |
Secondary | Identification of genetic profiles for pre-interventional prediction of expected disease progression | Identification of genetic profiles in the peripheral blood for pre-interventional prediction of expected disease progression as well as therapy monitoring | Within 1 week after measurement |
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