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
- Surigical procedure
N.a.
Outcome measures
Primary outcome
<p>RNA and protein expression profiles and morphology analysis of the human cochlea compared to inner ear organoids.</p>
Secondary outcome
<p>N/A</p>
Background summary
Pathologies of the inner ear are among the most significant global health problems and costs. Relatively little is known about these diseases, mainly due to the limited access to this organ (which makes it very difficult to study). Apart from technical devices such as hearing aids and cochlear implants, there are no real therapeutic options yet.
It is essential to increase our knowledge about the human cochlea: its anatomy, development, pathologies, and gene and protein expression profiles. Additionally, there has recently been a development in generating inner ear organoids from human-induced pluripotent stem cells. To compare this promising cellular model with their real adult human counterpart, it is also necessary to acquire adult cochlear human tissue. Providing more knowledge about the human adult cochlea will benefit both researchers and physicians worldwide.
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.
H Locher
Albinusdreef 2
Leiden 2333ZA
Netherlands
0715262434
KNO-onderzoek@lumc.nl
H Locher
Albinusdreef 2
Leiden 2333ZA
Netherlands
0715262434
KNO-onderzoek@lumc.nl
Trial sites in the Netherlands
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
Medical products/devices used
IPD sharing statement
Plan description
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 |
Research portal | NL-006988 |