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

NCT ID: NCT01808937

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2028-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Scleroderma, Localized Morphea Frontal Linear Scleroderma en Coup de Sabre Scleroderma, Circumscribed Scleroderma, Linear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Morphea

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

Morphea

Intervention Type OTHER

Interventions

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Morphea

Intervention Type OTHER

Other Intervention Names

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Scleroderma, Localized Scleroderma, Circumscribed Scleroderma, Linear Frontal Linear Scleroderma en Coup de Sabre

Eligibility Criteria

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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)
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Heidi Jacobe

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heidi Jacobe, MD, MSCS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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UT Southwestern Medical Center - Department of Dermatology

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Heidi Jacobe, MD, MSCS

Role: CONTACT

214.633.1837

Facility Contacts

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Heidi Jacobe, MD, MSCS

Role: primary

214.633.1837

Related Links

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Other Identifiers

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032007021; STU 112010-028

Identifier Type: -

Identifier Source: org_study_id

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