Data Collection Protocol for Patients With Von Hippel Lin... | NCT05955014

Studies
Data Collection Protocol for Patients With Von Hippel Lindau Disease

NCT05955014

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

Jun 26, 2026Actual

Enrollment

125Estimated

Phase

Not provided

Conditions

Von Hippel Lindau Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2023-05216	Other Identifier	NCI-Clinical Trials Registry

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 24, 2023Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jul 10, 2023

First Submission Date that Met QC Criteria

Jul 18, 2023

First Posted Date

Jul 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2026

Last Update Posted Date

Jun 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)		through study completion; an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

M D Anderson Cancer Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eric Jonasch, MD	Contact	(713) 563-7232		ejonasch@mdanderson.org

Overall Officials

Name	Affiliation	Role
Eric Jonasch, MD	ejonasch@mdanderson.org	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States

Label	URL
M D Anderson Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D006623	von Hippel-Lindau Disease

Ancestor Terms

ID	Term
D020752	Neurocutaneous Syndromes
D009422	Nervous System Diseases
D000798	Angiomatosis
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided