Registry Information
The Morphea Registry is set up for the registration and data collection of all individuals with a confirmed diagnosis of all subtypes of morphea. Unaffected pediatric controls may also participate. Controls are non-blood related individuals who are not affected with an autoimmune disease (click here for a list of autoimmune diseases) and do not live in the same household with a morphea patient.
A registrant must fulfill both:
1) have a confirmed diagnosis of morphea (if the diagnosis is unclear, a skin biopsy will be performed)
2) be available for annual follow up via provided contact information.
No treatment is offered in this registry and it is purely for data collection purposes. However, by registering, all participants will be made aware of new clinical trials that may be offered in the future and kept abreast of research discoveries.
Enrollment Information
All files may be completed and returned in several ways:
Complete with text in pdf and return via email to morphearegistry@utsouthwestern.edu.
Print and complete by hand and fax to (214) 645-8972 or mail to:
Dermatology Clinical Research Studies Unit
5323 Harry Hines Blvd, DF4.130A
Dallas, TX 75390-8802
Consent Form and HIPAA release
The nine page consent form outlines the details of the project, including the risks and benefits of participation. Consent for those less than 18 years of age must be given by the participants parent or legal guardian. In the case of participants between the ages of 10 and 18 years, assent from the participant is necessary. You will be given a copy of the signed consent form for your records.
The two page HIPAA (Health Insurance Portability and Accountability Act) release allows researchers to review your medical record only for the purposes of this study in order to obtain prior labs and disease records. Consent for those less than 18 years of age must be given by the participants parent or legal guardian. For more information, visit the HIPAA website.
Morphea Consent and HIPAA form (pdf)
Quality of life questionnaire
We understand that morphea can have a significant impact on people's life both socially and occupationally. This questionnaire will help us gather such information so that it may be recognized by others, such as research funding institutions.
Quality of life questionnaire (children <10 years of age)
Quality of life questionnaire (children 10-16 years of age)
Quality of life questionnaire (16 years of age of older)
Participant Forms
Participant forms capture contact information, age, sex, ethnicity, age of onset, severity and disease duration, associated symptoms, other autoimmune diseases and family status of morphea or other autoimmune diseases. There are six forms required as part of your participation divided according to the type of information gathered. All participants will also complete a standardized quality of life survey (10 questions) that will help us understand the impact of this disease on your daily life. We hope to use this information in research proposals in the future base research grants on knowledge of disease impact.
Contact information and demographics (pdf)
Disease history questionnaire (pdf)
Treatment history (pdf)
Clinical symptoms and investigations (pdf)
Personal or familial autoimmune disease history (pdf) - Will be available shortly.
Morphea diagram (pdf)- Fill in the diagram based on the distribution and onset of your lesions if you do not plan to visit UT Southwestern for enrollment. Will be available shortly.
Researchers familiar with the study protocol will review the questionnaires and contact you regarding questions. Participants determined to have morphea will be enrolled into the registry and complete blood work as part of the study (can be performed at UT Southwestern research visit or at an outside facility at no cost to the participant). This blood work will be used to obtain DNA, blood markers of disease (auto-antibodies) and lymphocytes for isolation. As part of enrollment, we will invite the participant to visit the Dermatology Clinical Research Unit at UT Southwestern (see below for directions and phone contacts) for digital photography and dermatologist performed physical examination.
Due to limited funding, only participants with a confirmed diagnosis of morphea (per review by our research committee) will be enrolled in the study. About 500 patients will be enrolled in the morphea registry and this number is limited by the cost associated with laboratory work and clinical time on the part of the investigators.
Directions to Clinical Building 1 (CB1) : At this link, CB1 is building 13. If traveling on I-35E, exit Inwood Drive and head east. You will take the right-side loop onto Harry Hines traveling north. At the intersection of Exchange Park and Harry Hines, turn left adn park where you would like. Enter at the covered entranceway and proceed to the 4th floor. Walk passed the dental office and enter a long hallway. The last door to your right is the Dermatology Clinical Research Trials Unit.
Contact: Memoree Lee at (214) 645-8973 if you need further directions or assistance.
