Ectodermal Dysplasias International Registry

Participate in the Ectodermal Dysplasias International Registry. Click Here.

The Registry is a resource by which individuals and families affected by ectodermal dysplasias and researchers working on approved ectodermal dysplasias research projects can be connected. The Registry will also help to characterize the ectodermal dysplasias.

We encourage you to complete a profile for the Ectodermal Dysplasias International Registry.

 

Clinical trials are a crucial part of finding treatments and cures for ectodermal dysplasias. Clinical research is the way that drugs, devices or other treatments are tested in humans to see if they are safe and effective. For instance, Edimer Pharmaceuticals is planning to implement clinical trials in 2011 to test the use of EDI200, a protein therapy, to treat the symptoms of patients affected by X-linked hypohidrotic ectodermal dysplasia. Recruitment for clinical trials can often take a long period of time, especially for rare disorders like ectodermal dysplasias. A Registry can speed up that process. It is a key first step not only for the EDI200 clinical trials, but all ectodermal dysplasias clinical studies.

What is a Registry?

A Registry is a central, online database that identifies and registers patients with any form of ectodermal dysplasia, collects and stores their information, and make this information available to investigators interested in studying the disorder. It includes personal and clinical information.

The Registry facilitates research by all investigators who need patient populations that are well characterized by accepted criteria. Once established, a Registry is a research resource that can support many diverse types of investigation and clinical trials performed by other investigators. It provides critical structure and uniformity to research, and it enables investigators to pursue promising research directions.

By registering information with the Ectodermal Dysplasias International Registry, you are in no way committing yourself to participate in any research project.

Vision

The vision is to establish an international Registry that will ultimately serve as a repository of clinical information from people affected by ectodermal dysplasias, both the more common and the rarer disorders, to achieve the stated goal.

Goal

The goal of the Registry is to facilitate communication between affected individuals, clinicians involved in their treatment and scientists who strive to advance the research on ectodermal dysplasias.

Objectives

• Characterize and describe the ectodermal dysplasias population.
•  Assist the development of recommendations and standards of care.
• Facilitate in the planning of clinical trials.
• Accelerate and facilitate clinical trials by locating potential research participants quickly and efficiently.

Who Coordinates the Registry?

The NFED is proud to establish and maintain the Registry with partial support from Edimer Pharmaceuticals. The following international ectodermal dysplasia groups are also participating.

• Australia - ozED
• Austria/Germany - Selbsthilfegruppe Ektodermale Dysplasie
• Belgium
• Denmark - Ectodermal Dysplasia Denmark
• France - Associacion Francaise Dysplasias Ectodermiques (AFDE)
• Italy - Associazione Nazionale Displasia Ectodermica (A.N.D.E.)
• Mexico - Asociacion Mexicana de Displasia Ectodermica
• Netherlands/Belgium/Luxemborg - Ectodermal Dysplasia the Netherlands
• Norway - Norsk ED-forening
• Spain - Asociacion de afectados por displasia ectodermica (A.A.D.E.)
• Sweden - Svenska Ed-foreningen
• Turkey - Ektodermal Displazi Grubu – Turkiye
• United Kingdom - Ectodermal Dysplasia Society

Who Should Participate?

We need every person affected by any kind of ectodermal dysplasia in every country to participate in the Registry. The NFED is working with the other patient support groups for ectodermal dysplasia throughout the world so their members can participate as well. The success of this project requires all of our participation and support in order to reach all affected individuals who might benefit from any treatment.

How Can I Participate in the Registry?

The Ectodermal Dysplasia International Registry launched on March 1, 2010 in English. Additional languages will be added as required. The Registry is Web-based so you must register online.

You will complete a detailed, informed consent. The informed consent will outline the goals and intent of the Registry and how the information will be used. You must give consent prior to participating.

Next, you will complete a distinct profile for each person in your immediate family who is affected by ectodermal dysplasia. To add additional family members, simply go to “My Profile” and “add family member”. In the profile, you will provide the following:

• personal information (such as name, age, sex); and
• clinical information (type of ectodermal dysplasia, symptoms, type of treatment received).

To maintain a valid Registry, it is important that you keep your profile updated. If you move, change your email address or phone number, you will need to update your profile.

Will My Information Be Private?

The NFED is committed and obligated to ensure the privacy of all individuals who participate in the Registry. The United States has extremely stringent laws in place to protect the privacy of identifiable health information for all individuals. The Web-based software program that NFED will be using for the Patient Registry, Innolyst, is compliant with The Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Researchers who are interested in studying ectodermal dysplasias can request de-identified information. De-identified information does not contain any names or personal identifiers, and can be given to approved researchers without having to contact Registry families. Identifiable information includes information that can identify you and will never be released to researchers. Identifiable information includes data such as names and dates of birth. Researchers may also request contact with families to obtain specific information or to request participation in a research study or clinical trial. These researchers will have to have institutional review board approval from their institution and be approved by a Scientific Review Board.  After approval, you will be contacted by the NFED Registry Program Director or Coordinator with the information.  You can decide if you want to contact the researcher for more information and choose to participate in the clinical trials.

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