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SHENCT07889960

Development of a Cloud Platform for Advanced Diagnostics Based on Clinical and Omics Data.

StatusCompleted
PhaseNot specified
Primary completion
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Assessment of the usability and usefulness of the SHE system
Timeframe: Up to October 2025

Arms and interventions

monogenic SAID

Patients with clinical and genetic findings consistent with a monogenic SAID belonging to one of the following categories: inflammasomopathies, unfolded protein response (UPR) and cellular stress disorders, type I interferonopathies, actinopathies, NF-κB hyperactivation disorders, or DADA2. Physician Global Assessment (PGA) \> 2 on a 0-10 visual analogue scale (VAS) and elevated C-reactive protein (CRP) levels.

Multifactorial/complex SAID

Patients with clinical manifestations consistent with PFAPA, SURF (as defined in Papa R et al., 2020), chronic recurrent multifocal osteomyelitis (CRMO)/SAPHO syndrome, or systemic juvenile idiopathic arthritis (sJIA). Physician Global Assessment (PGA) \> 2 on a 0-10 visual analogue scale (VAS) and elevated C-reactive protein (CRP) levels.

undifferentiated SAID

Patients with clinical manifestations consistent with a SAID, after excluding defined monogenic or multifactorial/complex autoinflammatory diseases based on clinical and/or genetic findings. Physician Global Assessment (PGA) \> 2 on a 0-10 visual analogue scale (VAS) and elevated C-reactive protein (CRP) levels.

Fibromyalgia

Widespread pain with symptoms persisting for at least 3 months. Patients meeting the clinical criteria defined in Wolfe et al. (2016).

Sites

3 sites in 1 country