- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05955014
Data Collection Protocol for Patients With Von Hippel Lindau Disease
April 5, 2024 updated by: M.D. Anderson Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
125
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric Jonasch, MD
- Phone Number: (713) 563-7232
- Email: ejonasch@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Eric Jonasch, MD
- Phone Number: 713-563-7232
- Email: ejonasch@mdanderson.org
-
Principal Investigator:
- Eric Jonasch, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
M D Anderson Cancer Center
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (PFS)
Time Frame: through study completion; an average of 1 year
|
through study completion; an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Jonasch, MD, ejonasch@mdanderson.org
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
July 10, 2023
First Submitted That Met QC Criteria
July 18, 2023
First Posted (Actual)
July 20, 2023
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0665
- NCI-2023-05216 (Other Identifier: NCI-Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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