Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository

Overview

The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country. The purpose of the registry is to learn more about morphea, specifically: – How morphea behaves over time – How frequently specific problems occur along with morphea (for example, arthritis) – Whether morphea has an autoimmune background

Full Title of Study: “Immunologic and Genetic Profiles in Subsets of Morphea Patients”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2022

Interventions

  • Other: Morphea

Arms, Groups and Cohorts

  • Morphea
    • Those having the condition morphea or other synonymous diagnosis (such as localized scleroderma, linear scleroderma, Parry-Romberg syndrome, en coup de sabre)

Clinical Trial Outcome Measures

Primary Measures

  • Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
    • Time Frame: 5 years

Secondary Measures

  • Quality of life scores measured by the Dermatology Life Quality Index (DLQI)
    • Time Frame: 5 years

Participating in This Clinical Trial

Inclusion Criteria

1. Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination. 2. Ages 0-90 years old 3. Children must weigh more than 20 lbs. in order to satisfy Children's Medical Center policy for the maximum amount of blood drawn in a 24 hour period. 4. Patient or legal guardian must be able to speak and read at a 6th grade reading level. 5. Both male and female patients will be eligible 6. All races and ethnic backgrounds will be included 7. Relationships to proband: All patients with morphea will be included. A patient'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'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. 8. 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. Exclusion Criteria:

  • Patients who have been coded as morphea (701.0), but do not have morphea/localized scleroderma (examples: steroid atrophy, acquired keratoderma, keloids, nephrogenic fibrosing dermopathy, systemic sclerosis, lichen sclerosis)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Texas Southwestern Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Heidi Jacobe, PROFESSOR – University of Texas Southwestern Medical Center
  • Overall Official(s)
    • Heidi Jacobe, MD, MSCS, Principal Investigator, University of Texas Southwestern Medical Center
  • Overall Contact(s)
    • Heidi Jacobe, MD, MSCS, 214.633.1837, heidi.jacobe@utsouthwestern.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.