FREQUENTLY ASKED QUESTIONS
WHAT IS THE VASCULAR EHLERS-DANLOS SYNDROME (VEDS) RESEARCH COLLABORATIVE STUDY?
This is a natural history study to define the contribution of known vEDS gene mutations to vEDS complications and outcomes. This will be achieved by the following:
Describe the genotype-phenotype correlation between vEDS gene mutations and complications. These complications include aortic and arterial pathology (e.g. fistulas, aneurysms and dissections, vein and artery clots), gastrointestinal complications (e.g. bowel perforation, bowel obstruction), pulmonary complications (e.g. pneumothorax), uterine rupture, and other complications related to vEDS.
To evaluate long -term outcomes of medical and surgical management of the vEDs complications and correlate the outcomes to the underlying genetic mutations.
To understand the additional modifiers that can lead to complications such as environmental factors (e.g. diet and exercise), medical management factors, and surgical interventions factors.
This work will lead to:
Creating treatment guidelines based on the underlying gene mutation
Discovering and/or create novel medical practices, diagnostic tools, protective therapies and medicines for the future that will prevent and/or cure the complications of vEDS.
HOW DOES ONE ENROLL?
You can enroll directly by contacting the study team at (206) 353-3076 or email@example.com. We are also collaborating with EDS.org, the Marfan Foundation, and Backpack. If you enroll into any of these registries then you can also tell them you want to enroll into vEDS Collaborative Study.
We then we mail or email you your consent packet. A week later, a University of Washington study coordinator will contact you to discuss this study in depth prior to signing any consent documentation and ensure that all of your questions have been answered. If you are eligible and would like to join the study, we will talk you through signing and sending back the forms included in this packet.
HOW IS THE VEDS RESEARCH COLLABORATIVE STUDY RELATED TO THE OVERALL VEDS RESEARCH COLLABORATIVE WORK?
The vEDS Research Collaborative work is dedicated to supporting the vEDS community in driving patient-centered scientific research to improve the management of vascular Ehlers-Danlos Syndrome and increase the quality of life for all those impacted by the disease. The vEDS Collaborative work is funded by the Patient Centered Outcomes Research Institute (PCORI) and is dedicated to establishing research priorities.
The purpose of this specific vEDS Collaborative Study is to consent patients with molecular confirmation of vEDS and to obtain their medical records and radiologic imaging to support a natural history study where the course of vEDS can be followed. This is very important, as it will help us learn more about the disease and guide future care and treatment options.
The study also creates an opportunity to reach out directly to patients and invite them to participate in additional clinical trials and information gathering surveys.
WHO IS ELIGIBLE TO ENROLL?
You must have molecular confirmation of the vEDS diagnosis (genetic testing results or skin biopsy results)
If you would like to have a genetic test to qualify, visit here for genetic testing options.
You must be 18 and over
WHAT SECURITY DOES THE RESEARCH STUDY HAVE?
All study data are stored on secure, encrypted servers at the University of Washington. All of the information you provide will be confidential. All study activities have been reviewed by the University of Washington Human Subjects Division to ensure maximum protection of human subjects research rights.
WILL THE RESEARCH DATA BE SHARED WITH OTHER RESEARCHERS?
Yes – currently we are partnered with other registries (such as Montalcino Aortic Consortium or GenTAC Alliance) for sharing deidentified data only. This means that your name and contact information will not be shared with other researchers.
WILL THE RESEARCH STUDY DATA BE SOLD?
No – the UW research study data will not be sold to any other entity.
CAN I CHANGE MY MIND?
Absolutely! Being part of the study is voluntary and you can change your mind at any time. Your medical care will not be affected if you decide not to participate in this study. You would not receive any medical treatment or genetic results by participating in this study.