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

This study is currently recruiting participants.
Verified December 2014 by University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01808937
First Posted: March 11, 2013
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  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 ]

Secondary Outcome Measures:
  • Quality of life scores measured by the Dermatology Life Quality Index (DLQI) [ Time Frame: 5 years ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01808937     History of Changes
Other Study ID Numbers: 032007021
First Submitted: February 25, 2013
First Posted: March 11, 2013
Last Update Posted: December 4, 2014
Last Verified: December 2014

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