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Data Collection Protocol for Patients With Von Hippel Lindau Disease

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05955014
Collaborator
(none)
125
Enrollment
1
Location
29
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    125 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Data Collection Protocol for Patients With Von Hippel Lindau Disease
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (PFS) [through study completion; an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Eric Jonasch, MD, ejonasch@mdanderson.org

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05955014
    Other Study ID Numbers:
    • 2022-0665
    • NCI-2023-05216
    First Posted:
    Jul 20, 2023
    Last Update Posted:
    Jul 20, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Von Hippel-Lindau Disease

    Study Results

    No Results Posted as of Jul 20, 2023