WES of NF2-associated in Comparison to Sporadic Vestibula... | NCT03210285

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

NCT03210285

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Jul 23, 2018Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Neurofibromatosis Type 2
Vestibular Schwannoma
Acoustic Neuroma

Interventions

Whole exome sequencing

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2017Actual

Primary Completion Date

Apr 1, 2018Actual

Completion Date

Jul 1, 2018Actual

First Submitted Date

Jul 3, 2017

First Submission Date that Met QC Criteria

Jul 4, 2017

First Posted Date

Jul 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2018

Last Update Posted Date

Jul 23, 2018Actual

Name	Class
National Center for Tumor Diseases, Heidelberg	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whole exome sequencing	Diagnostic Test	Whole exome sequencing	NF2-associated VS Sporadic VS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Study population: Operated NF2-associated VS
Control group: Operated sporadic VS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Schuhmann, Prof. Dr.	University Hospital Tübingen	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Department of Neurosurgery Tübingen		Tübingen		72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016518	Neurofibromatosis 2
D009464	Neuroma, Acoustic

Ancestor Terms

ID	Term
D009442	Neurilemmoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059472	Exome

Ancestor Terms

ID	Term
D016678	Genome
D040342	Genetic Structures
D055614	Genetic Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided