Screening for tumors in patients with von Hippel-Lindau disease
An International Collaborative Study: Screening for Endolymphatic Sac Tumours (ELSTs) in Von Hippel-Lindau (vHL) Patients
University of Copenhagen · NCT02420067
This study is testing the best ways to find small tumors in the ears of people with von Hippel-Lindau disease to help catch them early and prevent hearing loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 380 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Copenhagen (other) |
| Locations | 1 site (Copenhagen, Copenhagen N) |
| Trial ID | NCT02420067 on ClinicalTrials.gov |
What this trial studies
This study investigates the best methods for screening endolymphatic sac tumors (ELSTs) in patients with von Hippel-Lindau (vHL) disease to enable early diagnosis and prevent hearing loss. It involves conducting audiological examinations and MRI scans of the inner ear in vHL patients, regardless of whether they exhibit symptoms. The goal is to identify tumors while they are still small, as early detection can lead to better outcomes and preservation of hearing. The study aims to clarify optimal screening strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with von Hippel-Lindau disease who are at least 15 years old.
Not a fit: Patients under the age of 15 or those without a diagnosis of von Hippel-Lindau disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of hearing loss in vHL patients by enabling earlier detection of tumors.
How similar studies have performed: Previous studies have indicated the importance of early detection of ELSTs in vHL patients, suggesting that this approach may be beneficial, although specific screening strategies have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen, Copenhagen N
- Department of Cellular and Molecular Medicine, University of Copenhagen — Copenhagen, Copenhagen N, Denmark (RECRUITING)
Study contacts
- Principal investigator: Marie Luise Bisgaard, M.D. — Department of Cellular and Molecular Medicin, University of Copenhagen
- Study coordinator: Marie Luise Bisgaard, M.D.
- Email: mlbi@sund.ku.dk
- Phone: 004531333582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Von Hippel-Lindau Disease, von Hippel-Lindau disease, Endolymphatic sac tumors, Audiological examination, MRI, Surveillance