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Clinical Trials in Italy / NCT06808672
Active, not recruiting Observational

Biomarkers of Cancer-Associated Myositis

NCT06808672 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda USL Reggio Emilia - IRCCS
Phase
Observational
Started
2019-06-13
Last updated
2026-05-05

Condition(s) studied

Dermatomyositis

Study summary

The project is about dermatomyositis (DM), an autoimmune disease characterized by inflammation in the skeletal muscles and skin. Patients with DM have an increased risk of cancer, with a cancer incidence between 5.5% and 42%. Cancers in these patients are one of the leading causes of death. Some myositis-specific autoantibodies have been discovered and some of them are associated with cancer development. However, DM patients negative for all the known autoantibodies can also develop cancer. The Investigator hypothesized that antibodies against plasma membrane antigens and soluble immune checkpoints can be responsible for the association between cancers and autoimmunity. Therefore, the present study aimed to identify novel antigens and immunological pathways in patients with DM with cancer versus patients with DM without cancer, to identify those patients who need cancer screening. The Investigators focus on soluble immune checkpoint molecules and autoantibodies directed against plasma membrane antigens.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \> 40 years. * Diagnosis of DM. * Informed Consent Exclusion Criteria: * Chemotherapy at the time of the peripheral venous blood draw. * Therapy with biologic drugs at the time of the peripheral venous blood draw. * Necrotizing autoimmune myopathy.

Primary outcome measure(s)

  • Identification of autoantibodies against surface proteins in patients with dermatomyositis (DM) with and without cancer. — At enrollement
    Serum samples from patients with DM with and without cancer will be tested for their ability to bind various cell lines surface antigens through immunofluorescence assays on live cells. Median fluorescence intensity will be evaluated. These analyses will determine whether there are differences in the levels of autoantibodies between the serum samples from patients with and without cancer. Potential autoantigens will be identified by immunoprecipitation of cell lysates with sera followed by mass spectrometry.
  • Identification of soluble immune checkpoint molecules in patients with dermatomyositis (DM) with and without cancer. — At Enrollment
    Levels of 14 soluble immune checkpoint molecules will be quantified in serum samples using the Magpix technology (ProcartaPlex Immuno-Oncology Checkpoint Panel 1). The target molecules include: BTLA, GITR, HVEM, IDO, LAG-3, PD-1, PD-L1, PD-L2, TIM-3, CD28, CD80, CD137, CD27, and CD152. Concentrations of soluble immune checkpoints will be evaluated. These analyses will determine whether there are differences in the levels of these molecules between the serum samples from patients with and without cancer.

Trial sites (2)

FacilityCityRegionStatus
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari Bari Italy
AUSL-IRCCS di Reggio Emilia Reggio Emilia Italy

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Other trials for the same condition

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy Enrolling by invitation
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis Active, not recruiting
Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06808672 on ClinicalTrials.gov ↗ ← All trials in Italy