Immunologic and Genetic Profiles in Subsets of Morphea Patients

Study ID
STU 112010-028

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Noelle Teske
801/556-6604
noelle.teske@utsouthwestern.edu

Principal Investigator
Heidi Jacobe

Summary

This is a case-control study of adult and pediatric morphea patients (patients with morphea will be compared to 'normal' and systemic sclerosis patients) comparing clinical characteristics, autoimmune blood markers, autoimmune disorders, and family history of autoimmune disorders between morphea patients and age-, sex-, and race-matched 'normal' and systemic sclerosis controls. This study will be transformed into a prospective cohort (morphea patients will be followed over time) of adult and pediatric morphea patients that will be reevaluated yearly to investigate the natural history, presence of co-morbidities, and response to treatment of these patients. as part of a multi-site study, specimens and/or data will also be collected from pediatric morphea patients at Children's Mercy Hospital and Clinics, Kansas City, Mo, the Mayo Clinic, Rochester, Mn, and Hackensack unviversity Medical Center, Hackensack, nJ. This work is pioneering in that it will be the first investigation into the natural history of morphea in both adult and pediatric populations.

Participant Eligibility

4.1 Criteria for Inclusion of Subjects
4.1.1 Morphea patients x
a) Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination.
b) Ages 0-90 years old
c) Children must weigh more than 20 lbs. in order to satisfy Children[Single Quote]s Medical Center policy for the maximum amount of blood drawn in a 24 hour period.
d) Patient or legal guardian must be able to speak and read English or Spanish at a 6th grade reading level. A translator will be available with additional consent forms in Spanish.
e) Both male and female patients will be eligible
f) All races and ethnic backgrounds will be included
g) Relationships to proband: All patients with morphea will be included. A patient[Single Quote]s family history will be reviewed and if there is a family history of morphea or systemic sclerosis then we will give the study patient the investigator[Single Quote]s contact information and ask the family member to call the study team to answer any questions and enroll them in the study if they choose to do so.
h) Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor to be a part of the morphea registry.

4.1.2 [?]Normal[Single Quote] controls x
a) [?]Normal[Single Quote] patients must be seen at the UT Southwestern Dermatologic Surgery Clinic and have undergone a procedure that resulted in creation of surgical waste by no other action than the procedure itself.
b) Ages 0-90 years old
c) Children must weigh more than 20 lbs. in order to satisfy Children[Single Quote]s Medical Center policy for the maximum amount of blood drawn in a 24 hour period.
d) Patient or legal guardian must be able to speak and read English at a 6th grade reading level.
e) Both male and female patients will be eligible
f) All races and ethnic backgrounds will be included
g) Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor.

4.1.3 Systemic Sclerosis controls x
a) Systemic Sclerosis controls must be seen at the UT Southwestern Dermatology and or Rheumatology Clinic and have an American College of Rheumatology (ACR) criteria confirmed diagnosis of systemic sclerosis (Diffuse, Limited Cutaneous, CREST syndrome, etc).
b) Ages 0-90 years old
c) Children must weigh more than 20 lbs. in order to satisfy Children[Single Quote]s Medical Center policy for the maximum amount of blood drawn in a 24 hour period.
d) Patient or legal guardian must be able to speak and read English at a 6th grade reading level.
e) Both male and female patients will be eligible
f) All races and ethnic backgrounds will be included
g) Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor.