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Clinical Trial Details — Status: Completed

Administrative 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

Study information

Verified date July 2017
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.

The analysis of genetic changes should provide a better insight into the oncogenesis of these tumors. The distinct genetic characteristics between NF2-associated and sporadic VS suggest a different oncogenesis of these tumors.

The correlation of the genetic characteristics with the partly very different clinical appearance and a very different dynamics of the disease, in particular the tumor volume in the course, identifies the underlying modifiers of the disease course.

Based on these genetic modifiers, patients can be stratified and individual clinical therapy decisions can be made.

By demonstrating these genetic profiles in the peripheral blood, prospective conclusions can be drawn about expected disease progression before intervention as well as for therapy monitoring


Recruitment information / eligibility

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)

Study Design


Intervention

Diagnostic Test:
Whole exome sequencing
Whole exome sequencing

Locations

Country Name City State
Germany University Department of Neurosurgery Tübingen Tübingen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Tuebingen National Center for Tumor Diseases, Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

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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