Data Collection Protocol for Patients With Von Hippel Lindau Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Von Hippel Lindau Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
To collect information from patients with vHL disease. Information collected will include data on the status of the disease, any surgeries or therapies patients have received for vHL disease, and quality of life.
Detailed description
Primary Objectives:
* Obtain prospective and retrospective data on lesion development, surgical history and systemic therapy use in patients with vHL disease * Assess genotype-phenotype correlation between VHL mutation type and patterns of lesion development * Assess genotype-phenotype correlation for response to belzutifan in an organ-specific manner
Secondary Objectives:
--Obtain quality of life data in patients with vHL disease
Primary outcome measures
- Progression-free survival (PFS) [Time frame: through study completion; an average of 1 year]
Eligibility criteria
Inclusion criteria
- Presence of genetic confirmation or clinical criteria consistent with vHL disease.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05955014 · 2022-0665 · NCI-2023-05216