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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05955014
Other study ID # 2022-0665
Secondary ID NCI-2023-05216
Status Recruiting
Phase
First received
Last updated
Start date August 24, 2023
Est. completion date December 31, 2026

Study information

Verified date August 2023
Source M.D. Anderson Cancer Center
Contact Eric Jonasch, MD
Phone (713) 563-7232
Email ejonasch@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 125
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival (PFS) through study completion; an average of 1 year
See also
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