NCT03749980

Brief Summary

MyVHL is a multi-patient database which helps researchers identify patterns across VHL patients. MyVHL provides you -and researchers -with more complete information about VHL, like how your lifestyle, medications, and other factors impact the disease and quality of life. These insights help you better understand the condition and help researchers know where to focus their efforts. Due to its rarity, there is less understanding of VHL and the factors that may have an impact. The data individuals provide in MyVHL helps researchers identify and uncover factors that may increase risk, inhibit or slow tumor growth, or lead to an effective cure.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2012Dec 2028

Study Start

First participant enrolled

January 1, 2012

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

16.9 years

First QC Date

May 30, 2018

Last Update Submit

April 25, 2024

Conditions

Von Hippel-Lindau DiseaseHereditary Leiomyomatosis and Renal Cell CancerBirt-Hogg-Dube SyndromeSDHB Gene Mutation

Keywords

VHLBHDHLRCCSDHBMyVHL

Outcome Measures

Primary Outcomes (2)

  • Number of patients with CNS, kidney, adrenal, retinal, thyroid, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, as they relate to VHL, BHD, HLRCC, and SDHB and specific genetic mutation.

    Data regarding changes in number of CNS, kidney, adrenal, retinal, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, over a lifetime.

    Through study completion, an average of 1 year.

  • Size of tumors in patients with CNS, kidney, adrenal, retinal, thyroid, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, as they relate to VHL, BHD, HLRCC, and SDHB and specific genetic mutation.

    Data regarding changes in size of CNS, kidney, adrenal, retinal, ear, and pancreatic tumors, along with cystadenomas and lesions in the lungs, liver and skin, over a lifetime.

    Through study completion, an average of 1 year.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with von Hippel-Lindau Disease (VHL)

You may qualify if:

  • All patients with von Hippel-Lindau Disease (VHL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VHL Alliance

Boston, Massachusetts, 02132, United States

RECRUITING

Related Publications (1)

  • Larcher A, Rowe I, Belladelli F, Fallara G, Raggi D, Necchi A, Montorsi F, Capitanio U, Salonia A; OSR VHL Program. Von Hippel-Lindau disease-associated renal cell carcinoma: a call to action. Curr Opin Urol. 2022 Jan 1;32(1):31-39. doi: 10.1097/MOU.0000000000000950.

    PMID: 34783716DERIVED

MeSH Terms

Conditions

von Hippel-Lindau DiseaseHereditary leiomyomatosis and renal cell cancerBirt-Hogg-Dube Syndrome

Condition Hierarchy (Ancestors)

Neurocutaneous SyndromesNervous System DiseasesAngiomatosisVascular DiseasesCardiovascular DiseasesCiliopathiesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornNeoplastic Syndromes, HereditaryNeoplasms

Study Officials

  • Joshua Mann, MPH

    VHL Alliance

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Mann, MPH

CONTACT

161727756674josh.mann@vhl.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Health

Study Record Dates

First Submitted

May 30, 2018

First Posted

November 21, 2018

Study Start

January 1, 2012

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

When participant information is stored, the investigators are careful to protect any patient identifying information from discovery by others. Strict security safeguards are in place to reduce the chance of misuse or unplanned release of information. Researchers will only use participant information in a de-identified manner. De-identified means that the researchers will use participant information without knowing their identity. In some cases, they may use some identifying information about the participant for research purposes, subject to an approval process through the VHL Alliance MyVHL Research Committee. At times, the researchers will use participant information with a code, instead of their name; the code would allow results of the research to be linked back to the participant.

Shared Documents
STUDY PROTOCOL, ICF

Locations

US(1)