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Trial record 22 of 109 for:    "Schwannoma"

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

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.

Condition or disease Intervention/treatment
Neurofibromatosis Type 2 Vestibular Schwannoma Acoustic Neuroma Diagnostic Test: Whole exome sequencing

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]
Actual Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Whole Exome Sequencing (WES) of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : July 1, 2018


Group/Cohort Intervention/treatment
NF2-associated VS
Patients after surgery of a NF2- associated vestibularis schwannoma: Whole exome sequencing of blood and tumor tissue
Diagnostic Test: Whole exome sequencing
Whole exome sequencing

Sporadic VS
Patients after surgery of a sporadic vestibularis schwannoma: : Whole exome sequencing of blood and tumor tissue
Diagnostic Test: Whole exome sequencing
Whole exome sequencing




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Tumor tissue Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Study population: Operated NF2-associated VS
  • Control group: Operated sporadic VS
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210285


Locations
Germany
University Department of Neurosurgery Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
National Center for Tumor Diseases, Heidelberg
Investigators
Study Director: Martin Schuhmann, Prof. Dr. University hospital Tübingen

Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03210285     History of Changes
Other Study ID Numbers: NF2Tue
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Tuebingen:
Whole exome sequencing
Neurofibromatosis Type 2
Acoustic Neuroma
Vestibular schwannoma

Additional relevant MeSH terms:
Neurilemmoma
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Neuroma
Neuroma, Acoustic
Neurofibromatosis 2
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Cranial Nerve Neoplasms
Neoplasms by Site
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases