Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06259292
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-01-22
Brief Title:
Comprehensive HHT Outcomes Registry of the United States CHORUS
Sponsor:
Cure HHT
Organization:
Cure HHT
Study Overview
Official Title:
CHORUS Comprehensive HHT Hereditary Hemorrhagic Telangiectasia Outcomes Registry of the United States
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHORUS
Brief Summary:
The Comprehensive HHT Outcomes Registry of the United States CHORUS is an observational registry of patients diagnosed with Hereditary Hemorrhagic Telangiectasia HHT The purpose of this study is to better understand HHT the symptoms and complications it causes and the impact the disease has on peoples lives The investigators will collect long-term information about the participant allowing us to understand how the disease changes over time and what factors can influence those changes Ultimately this should help improve treatments for the disease
Another important goal of the study is to provide a way to contact people to participate in future clinical trials and other research The registry will be a centralized resource for recruitment for clinical trials People in the registry will not be obligated to join any of these additional studies but if interested can agree to be contacted if they may be eligible for a study
Participants will
Be asked to provide permission to collect information from their medical records including things like demographic information diagnosis information family history test results treatment information symptoms complications lifestyle and other relevant medical information
Be asked study-related questions by phone or at a clinic visit
Be asked study-related questions every year after enrollment for up to 10 years or until the study ends A member of the study team will communicate with participants by phone or at clinic visits to collect information regarding any changes to their health over the previous years including new test results treatment information symptoms and complications from HHT
Another important goal of the study is to provide a way to contact people to participate in future clinical trials and other research The registry will be a centralized resource for recruitment for clinical trials People in the registry will not be obligated to join any of these additional studies but if interested can agree to be contacted if they may be eligible for a study
Participants will
Be asked to provide permission to collect information from their medical records including things like demographic information diagnosis information family history test results treatment information symptoms complications lifestyle and other relevant medical information
Be asked study-related questions by phone or at a clinic visit
Be asked study-related questions every year after enrollment for up to 10 years or until the study ends A member of the study team will communicate with participants by phone or at clinic visits to collect information regarding any changes to their health over the previous years including new test results treatment information symptoms and complications from HHT
Detailed Description:
The Comprehensive HHT Outcomes Registry of the United States CHORUS is a research initiative led by the HHT Foundation International Inc Cure HHT The study focuses on Hereditary Hemorrhagic Telangiectasia HHT a rare genetic disorder characterized by the development of abnormal blood vessels in various organs of the body including the brain spine lungs liver GI tract skin nasal mucosa and oral cavity The prevalence of HHT is estimated to be 1 in 5000 affecting children and adults These abnormal blood vessels can lead to acute and chronic bleeding stroke heart failure and death Treatments are currently predominately limited to managing complications while approximately 90 of adults have ongoing symptoms despite the best surgical and medical therapies With recent drug developments related to angiogenesis there is hope for effective novel therapies
A natural history registry for HHT has significant implications for improving the understanding and management of this rare genetic disorder The purpose of this study is to better understand HHT the symptoms and complications it causes outcomes and to understand how the disease impacts peoples lives The investigators hypothesize that a natural history registry for HHT will improve our understanding of the disease lead to better management of patients and ultimately contribute to developing novel therapies to treat this disease
The investigators will collaborate with multiple HHT Centers of Excellence across the US to establish a comprehensive registry of HHT patients The study aims to enroll approximately 10000 HHT patients over a 10-year period Longitudinal data will be collected both retrospectively and prospectively with a focus on increasing the understanding of this rare disease accelerating the development of new diagnostic and treatment options and working collaboratively with clinicians who care for individuals with HHT to identify and address gaps in the system of care especially those from underserved populations
The study aims to serve as a centralized resource for future clinical trials and research in HHT Data security and confidentiality are prioritized and participants have the option to withdraw from the study at any time The study is funded by the US Department of Health Resources and Service Administration HRSA through a grant awarded to Cure HHT
A natural history registry for HHT has significant implications for improving the understanding and management of this rare genetic disorder The purpose of this study is to better understand HHT the symptoms and complications it causes outcomes and to understand how the disease impacts peoples lives The investigators hypothesize that a natural history registry for HHT will improve our understanding of the disease lead to better management of patients and ultimately contribute to developing novel therapies to treat this disease
The investigators will collaborate with multiple HHT Centers of Excellence across the US to establish a comprehensive registry of HHT patients The study aims to enroll approximately 10000 HHT patients over a 10-year period Longitudinal data will be collected both retrospectively and prospectively with a focus on increasing the understanding of this rare disease accelerating the development of new diagnostic and treatment options and working collaboratively with clinicians who care for individuals with HHT to identify and address gaps in the system of care especially those from underserved populations
The study aims to serve as a centralized resource for future clinical trials and research in HHT Data security and confidentiality are prioritized and participants have the option to withdraw from the study at any time The study is funded by the US Department of Health Resources and Service Administration HRSA through a grant awarded to Cure HHT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None