National Cohort of Patients With SITRAME Syndrome

NCT07168746 | Not Yet Recruiting

• 1 other identifier: APHP250008
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

SITRAME syndrome is a recently described disease. In the absence of epidemiological data on SITRAME syndrome in France, the National Reference Center for Autoinflammatory Diseases proposes coordinating a database to collect both retrospective and prospective cases of this rare disease. Currently, there are no available data on the epidemiology or treatment of SITRAME syndrome in France or globally. The importance of this research is to provide an overview of demographic, etiological, and disease progression data for patients with SITRAME syndrome in France. This will allow the establishment of quantitative data on the morbidity and mortality of this rare disease.

Conditions

Auto Inflammatory Diseases

Keywords

SITRAME; autoinflammatory diseases; cohort

Outcome Measures

Primary Outcomes (6)

• Description of the sexe at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  Day 0- Baseline

• Description of the age at the diagnosis of the disease

  Description of the age at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  Day 0- Baseline

• Description of cardiovascular co-morbidity

  Description of cardiovascular co-morbidity at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  Day 0- Baseline

• Description of presence of an allergical context

  Description of presence of an allergical context in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  Day 0- Baseline

• Description of the different therapeutic lines

  Description of the different therapeutic lines in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  Year 15

• Description of the age at death

  Description of the age at death in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  Day 0- Baseline

Secondary Outcomes (28)

• Measure of the prevalence of this disease annually using the register of newly included patients

  Every year up to 15 years

• Measure of the incidence of this disease

  Every year up to 15 years

• Description of the rare clinical manifestations (outside of the well-established disease criteria)

  Year 15

• Description of the rare biological manifestations (outside of the well-established disease criteria)

  Year 15

• Measure of the number of patients eligible for various clinical research studies on SITRAME syndrome

  Every year up to 15 years

Eligibility Criteria

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

Study Population

Patients will be recruited in France via the national reference center for autoinflammatory diseases at Tenon Hospital (Internal Medicine, Dermatology and Allergology Department at Tenon Hospital).

You may qualify if:

• SITRAME syndrome meeting the diagnostic criteria for the disease
• All the following criteria must be met:
• Systemic inflammation: at least 1 documented episode of CRP \>5mg/mL during a skin flare
• Maculopapular rash on the trunk: fixed, non-itchy maculopapular rash on the trunk appearing within hours with clear borders
• Recurrence in the same areas: at least 3 different episodes
• Acute: duration less than 8 days
• And at least 1 of the following criteria:
• Fever during flare-ups
• Flare-ups triggered by infections, vaccinations, or intense physical exercise
• Fatigue during and/or after flare-ups
• Associated papular rash

You may not qualify if:

• No evidence of a monogenic autoinflammatory disease, evolving neoplasm, or evolving autoimmune disease.
• Patients not opposed to participating in the research
• \- Persons with special protection cannot be included in the study:
• Adults under guardianship or curatorship
• Hospitalized persons without consent and not legally protected
• Persons deprived of liberty

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• Angele SORIA, PUPH, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angele SORIA, PU-PH, MD, PhD

CONTACT

00 33 1 56 01 72 20; angele.soria@aphp.fr

Sophie GEORGIN-LAVIALLE, PUPH, MD, PhD

CONTACT

00 33 1 56 01 74 31; sophie.georgin-lavialle@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: September 11, 2025
• Study Start: September 1, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2055
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share