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

NCT07265999 | Recruiting

• 1 other identifier: PAP_RIPH3_2020/11
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatomyositis

Keywords

Dermatomyositis

Outcome Measures

Primary Outcomes (1)

• severity of dermatomyositis at diagnosis

  The primary outcome measure is the severity of dermatomyositis at diagnosis, defined by the presence of one or more of the following criteria: Muscle involvement resulting in functional disability; Associated visceral involvement, including the heart, lungs, or oropharyngeal region; Associated cancer, either previously diagnosed within the past three years or diagnosed concurrently with dermatomyositis.

  Assessed at baseline (diagnosis).

Secondary Outcomes (3)

• Mortality

  Assessed over 2 years from the date of dermatomyositis diagnosis

• Relapse Occurrence

  Assessed over 2 years from the date of dermatomyositis diagnosis

• Cancer Occurrence

  Assessed over 2 years from the date of dermatomyositis diagnosis

Study Arms (1)

Patients with dermatomyositis

All patient with dermatomyositis

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients (\>16 years old) diagnosed with dermatomyositis, including both classic dermatomyositis and clinically amyopathic dermatomyositis, regardless of sex or ethnicity. Eligible patients are those who have received a new diagnosis and can be followed for at least two years.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

CHU de la Guadeloupe

Pointe-à-Pitre, 97139, Guadeloupe

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Additional blood samples required for research, including HLA typing and serum interferon assays, will consist of up to three 3.5 mL dry tubes and one 5 mL EDTA tube (total 15.5 mL). HLA typing samples (1 × 5 mL EDTA tube) will be transported internally to the CHU Guadeloupe Immuno-Hematology Laboratory for processing. Serum interferon samples (3 × 3.5 mL tubes) will be sent to the CHU Guadeloupe Biobank (CRB), centrifuged, aliquoted into cryotubes, and stored at -80 °C until batch shipment to the processing site.

MeSH Terms

Conditions

Dermatomyositis

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• nadège cordel, MD PhD

  CHU de la Guadeloupe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

melanie petapermal, Master degree

CONTACT

+590590934667; melanie.petapermal@chu-guadeloupe.fr

Valérie Hamony Soter

CONTACT

+590590934677; valerie.soter@chu-guadeloupe.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 5, 2025
• Study Start: July 16, 2021
• Primary Completion (Estimated): July 16, 2029
• Study Completion (Estimated): July 16, 2029
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)