To study the human adult cochlea, in specific it*s RNA and protein expression patterns and morphology.
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
RNA and protein expression profiles and morphology analysis of the human
cochlea compared to inner ear organoids.
Secondary outcome
N/A
Background summary
Pathologieën van het binnenoor zijn een van de belangrijkste wereldwijde
gezondheidsproblemen en -kosten. Er is relatief weinig bekend over deze
ziekten, voornamelijk vanwege de beperkte toegang van dit orgaan (wat het erg
moeilijk maakt om te studeren). Afgezien van technische apparaten zoals
hoortoestellen en cochleaire implantaten, bestaan **er nog geen echte
therapeutische opties.
Het is essentieel om onze kennis over het menselijke slakkenhuis te vergroten:
het gaat om anatomie, ontwikkeling, pathologieën en gen- en
eiwitexpressieprofielen. Daarnaast is er recentelijk een ontwikkeling geweest
in het genereren van binnenoororganoïden uit door de mens geïnduceerde
pluripotente stamcellen. Om dit veelbelovende cellulaire model te vergelijken
met hun echte volwassen menselijke tegenhanger, is het ook noodzakelijk om
volwassen cochleair menselijk weefsel te verwerven. Het verstrekken van meer
kennis over de menselijke volwassen cochlea zal zowel onderzoekers als artsen
over de hele wereld ten goede komen.
Study objective
To study the human adult cochlea, in specific it*s RNA and protein expression
patterns and morphology.
Study design
Fundamental research
Intervention
Additional acquisition of cochlear tissue.
Study burden and risks
Included patients will undergo a translabyrinthine surgery, because of
standard medical care reasons (usually this is a vestibular schwannoma). This
is a major surgical intervention with a long duration (all day surgery) and
various significant risks (such as facial nerve paralysis, intercranial
haemorrhage, brain infection, liquorrhea). During and due to this intervention
patients will completely lose their remaining inner ear function (both cochlea
and vestibular system). However, the cochlear tissue will normally stay inside
the patient (even though with complete loss of function). To also access the
cochlea, the surgeon has to open up the inner ear a few millimeters outside of
the standard (translabyrinthine) surgical route. This is an extremely limited
extension of the entire translabyrinthine procedure. The only postoperative
difference for the included patients is that they will have an additional ear
tampon underneath their head bandage. In light of the translabyrinthine
approach and involved risks, there are no increased or additional risks for the
patient during this extended procedure.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- A planned translabyrinthine approach, part of standard medical care
- Preoperative good or residual hearing at the affected side
- Age 18 years and over, who have mastered the Dutch or English language
Exclusion criteria
Mentally incapacitated
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82900.058.23 |