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WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data (NF2)

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ClinicalTrials.gov Identifier: NCT03210285
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
National Center for Tumor Diseases, Heidelberg
Information provided by (Responsible Party):
University Hospital Tuebingen

Tracking Information
First Submitted Date July 3, 2017
First Posted Date July 6, 2017
Last Update Posted Date July 23, 2018
Actual Study Start Date July 31, 2017
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2017)
Correlation clinical-volumetric pathologies and distinct genetic features [ Time Frame: Within 1 week after measurement ]
Correlation between interindividually different clinical-volumetric pathologies and distinct genetic features
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 4, 2017)
Identification of genetic profiles for pre-interventional prediction of expected disease progression [ Time Frame: Within 1 week after measurement ]
Identification of genetic profiles in the peripheral blood for pre-interventional prediction of expected disease progression as well as therapy monitoring
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data
Official Title Whole Exome Sequencing (WES) of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data
Brief 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.
Detailed 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

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
Tumor tissue Blood
Sampling Method Non-Probability Sample
Study Population
  • Study population: Operated NF2-associated VS
  • Control group: Operated sporadic VS
Condition
  • Neurofibromatosis Type 2
  • Vestibular Schwannoma
  • Acoustic Neuroma
Intervention Diagnostic Test: Whole exome sequencing
Whole exome sequencing
Study Groups/Cohorts
  • NF2-associated VS
    Patients after surgery of a NF2- associated vestibularis schwannoma: Whole exome sequencing of blood and tumor tissue
    Intervention: Diagnostic Test: Whole exome sequencing
  • Sporadic VS
    Patients after surgery of a sporadic vestibularis schwannoma: : Whole exome sequencing of blood and tumor tissue
    Intervention: Diagnostic Test: Whole exome sequencing
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 Completed
Actual Enrollment
 (submitted: July 19, 2018)
70
Original Estimated Enrollment
 (submitted: July 4, 2017)
100
Actual Study Completion Date July 1, 2018
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03210285
Other Study ID Numbers NF2Tue
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital Tuebingen
Study Sponsor University Hospital Tuebingen
Collaborators National Center for Tumor Diseases, Heidelberg
Investigators
Study Director: Martin Schuhmann, Prof. Dr. University hospital Tübingen
PRS Account University Hospital Tuebingen
Verification Date July 2017