MyVHL: Patient Natural History Study (MyVHL)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03749980 |
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Recruitment Status :
Recruiting
First Posted : November 21, 2018
Last Update Posted : October 11, 2021
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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.
| Condition or disease |
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| Von Hippel-Lindau Disease Hereditary Leiomyomatosis and Renal Cell Cancer Birt-Hogg-Dube Syndrome SDHB Gene Mutation |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 10000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 1 Year |
| Official Title: | MyVHL: Patient Natural History Study |
| Actual Study Start Date : | January 2012 |
| Estimated Primary Completion Date : | December 2024 |
| Estimated Study Completion Date : | December 2024 |
- 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. [ Time Frame: Through study completion, an average of 1 year. ]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.
- 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. [ Time Frame: Through study completion, an average of 1 year. ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- All patients with von Hippel-Lindau Disease (VHL)
Exclusion Criteria:
-
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749980
| Contact: Joshua Mann, MPH | 161727756674 ext 4 | josh.mann@vhl.org |
| United States, Massachusetts | |
| VHL Alliance | Recruiting |
| Boston, Massachusetts, United States, 02132 | |
| Contact: Joshua Mann, MPH 617-277-5667 ext 4 josh.mann@vhl.org | |
| Principal Investigator: | Joshua Mann, MPH | VHL Alliance |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Joshua Mann, MPH, Director of Health, VHL Alliance |
| ClinicalTrials.gov Identifier: | NCT03749980 |
| Other Study ID Numbers: |
0001 |
| First Posted: | November 21, 2018 Key Record Dates |
| Last Update Posted: | October 11, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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VHL BHD HLRCC SDHB MyVHL |
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Carcinoma, Renal Cell Leiomyomatosis Birt-Hogg-Dube Syndrome Von Hippel-Lindau Disease Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Neurocutaneous Syndromes Nervous System Diseases Angiomatosis Vascular Diseases Cardiovascular Diseases Ciliopathies Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Leiomyoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplastic Syndromes, Hereditary |