Severity Factors of Dermatomyositis in the Caribbean Population - DM-ANTILLES

NCT ID: NCT07265999

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-16
• Study Completion Date: 2029-07-16

Brief Summary

Dermatomyositis is a rare chronic autoimmune and inflammatory disease that affects the skin and striated muscles. Its prognosis is linked to visceral involvement (lungs, heart, and oropharyngeal region) and to the possible presence of associated cancer. The implementation of the research will allow identification of incident cases of dermatomyositis in Guadeloupe and the characterization of the disease in the overseas population, in the absence of data in the literature.

Detailed Description

In the French West Indies, this condition is associated with high short- and medium-term morbidity and mortality. Diagnostic delays and patient care pathways may help explain this. However, a particularly severe phenotype of the disease in Antillean patients may also play a role, as observed in other autoimmune and inflammatory diseases we have described in overseas populations (e.g., systemic sclerosis, sarcoidosis).

Identifying factors associated with the severity of dermatomyositis at the time of diagnosis would allow for the early implementation of a tailored management strategy to improve the disease prognosis in the target population.

Conditions

Dermatomyositis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with dermatomyositis

All patient with dermatomyositis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient with a diagnosis of dermatomyositis according to the 2003 ENMC criteria
• Patient with parents or grandparents originating from the Caribbean arc
• Patient aged 16 years or older
• Patient residing in Guadeloupe
• Patient (or legal representative) who has received information about the study and has signed the informed consent form
• Patient affiliated with a social security scheme

Exclusion Criteria

• Patient who started treatment with intravenous immunoglobulins, corticosteroids, or immunosuppressants within the month prior to the diagnosis of dermatomyositis
• Patient under legal protection (guardianship or trusteeship) or deprived of liberty

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

nadège cordel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de la Guadeloupe

Locations

CHU de la Guadeloupe

Pointe-à-Pitre, , Guadeloupe

Site Status: RECRUITING

Countries

Guadeloupe

Central Contacts

melanie petapermal, Master degree

Role: CONTACT

melanie.petapermal@chu-guadeloupe.fr

+590590934667

Valérie Hamony Soter

Role: CONTACT

valerie.soter@chu-guadeloupe.fr

+590590934677

Facility Contacts

nadège cordel, MD PhD

Role: primary

nadege.cordel@chu-guadeloupe.fr

Other Identifiers

PAP_RIPH3_2020/11

Identifier Type: -

Identifier Source: org_study_id