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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01808937
First received: February 25, 2013
Last updated: March 8, 2013
Last verified: January 2013
  Purpose

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

Condition Intervention
Scleroderma, Localized
Morphea
Frontal Linear Scleroderma en Coup de Sabre
Scleroderma, Circumscribed
Scleroderma, Linear
Other: Morphea

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
Official Title: Immunologic and Genetic Profiles in Subsets of Morphea Patients

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life scores measured by the Dermatology Life Quality Index (DLQI) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, WBC, tissue


Estimated Enrollment: 500
Study Start Date: May 2007
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Morphea
Those having the condition morphea or other synonymous diagnosis (such as localized scleroderma, linear scleroderma, Parry-Romberg syndrome, en coup de sabre)
Other: Morphea
Other Names:
  • Scleroderma, Localized
  • Scleroderma, Circumscribed
  • Scleroderma, Linear
  • Frontal Linear Scleroderma en Coup de Sabre

  Eligibility

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Recruitment from clinic visits as well as from regional and national referrals.

Criteria

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808937

Contacts
Contact: Heidi Jacobe, MD, MSCS 214.633.1837 heidi.jacobe@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center - Department of Dermatology Recruiting
Dallas, Texas, United States, 75390-9069
Contact: Heidi Jacobe, MD, MSCS    214-633-1837    heidi.jacobe@utsouthwestern.edu   
Principal Investigator: Heidi Jacobe, MD, MSCS         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Heidi Jacobe, MD, MSCS University of Texas Southwestern Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01808937     History of Changes
Other Study ID Numbers: 032007021
Study First Received: February 25, 2013
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Scleroderma, Diffuse
Scleroderma, Localized
Scleroderma, Systemic
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 19, 2014