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Clinical Trials in Denmark / NCT02420067
Recruiting Observational

Screening for Endolymphatic Sac Tumours (ELSTs) in Von Hippel-Lindau (vHL) Patients

NCT02420067 · tracked via the Priya Life Science Denmark tracker
Sponsor
Marie Luise Bisgaard, MD
Phase
Observational
Started
2011-02
Last updated
2017-05-09

Condition(s) studied

Von Hippel-Lindau Disease

Study summary

The purpose of the study is to investigate how best to screen for Endolymphatic sac tumors (ELSTs) in von Hippel-Lindau (vHL) patients in order to diagnose the ELSTs while they are still small so that hearing loss can be prevented.

Up to 16% of vHL patients are known to develop endolymphatic sac tumors in the inner ear that can cause permanent hearing loss. However, the ELSTs are often not found before hearing loss has already occurred. The challenge for doctors is to diagnose the ELSTs at early stages before they cause often irreversible deafness. In order to find ELSTs before they cause hearing loss, it is important to screen for the tumors prophylactically, that is screen all vHL patients regardless of whether or not they have symptoms.

Who can join? Persons diagnosed with vHL who are at least 15 years old. The investigators include patients WITH OR WITHOUT a diagnosed ELST.

What does it involve? You need to have a hearing test and an MRI of the brain, where the inner ear can be seen, most vHL patients have already had this done as part of their surveillance program.

Participants will be asked to participate in follow up examinations (hearing test and/or MRI of the brain) after 2, 5, and 10 years.

How can I join? A doctor has to be responsible for the study in each country where vHL patients participates.

Ask the doctor who manages your vHL examinations to contact us or contact us yourself and the investigators will help you find a doctor in your country who will participate in the study.

Eligibility

Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * A diagnosis of vHL (either a carrier of a VHL mutation or vHL diagnosed by clinical criteria, i.e. at least two vHL-related manifestations diagnosed or one vHL-related manifestation diagnosed AND a first-degree relative with vHL) * At least one audiological examination (including an audiogramme) and one MRI examination of the brain also visualizing the inner ear within 12 months of each other Exclusion Criteria: * Children under the age of 15 years

Primary outcome measure(s)

  • In each ear: development of an ELST during the study period correlated to baseline hearing level. — Change in status of ELST diagnosis from during the ten year period from study baseline to study end.
    Presence and size of an ELST as diagnosed by an MRI at any time during the study period correlated to the baseline hearing level in the ear as defined by hearing level in decibel in air- and bone conduction at predefined frequencies 125, 250, 500, 1000, 2000, 4000, 8000 Hz measured with pure-tone audiometry.

Trial sites (1)

FacilityCityRegionStatus
Department of Cellular and Molecular Medicine, University of Copenhagen Copenhagen Copenhagen N Recruiting

Other trials for the same condition

Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) Recruiting
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02420067 on ClinicalTrials.gov ↗ ← All trials in Denmark