Biomarkers of Cancer-Associated Myositis

NCT06808672 | Active Not Recruiting DMC

• 1 other identifier: 419/2019/OSS/AUSLRE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dermatomyositis

Keywords

Dermatomyositis; Immune Checkpoints; Autoantibodies; Cancer Risk

Outcome Measures

Primary Outcomes (2)

• Identification of autoantibodies against surface proteins in patients with dermatomyositis (DM) with and without cancer.

  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.

  At enrollement

• Identification of soluble immune checkpoint molecules in patients with dermatomyositis (DM) with and without cancer.

  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.

  At Enrollment

Secondary Outcomes (3)

• Expression of autoantigens in muscle biopsy samples from DM patients and cancer samples

  At Enrollment

• Expression of autoantibodies against surface proteins in patients with dermatomyositis (DM) compared to healthy controls.

  At Enrollment

• Expression of soluble immune checkpoint molecules in patients with dermatomyositis (DM) compared to healthy controls.

  At Enrollment

Study Arms (3)

DM without cancer

Patients with DM who do not have cancer at diagnosis and in the 3-year follow-up period

DM with cancer

Patients with DM who have cancer at diagnosis or in the 3-years before or after DM diagnosis

Healthy controls

Subjects without known cancer, autoimmune diseases and infections

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with DM during rheumatologic visits of the national health system

You may qualify if:

• Age \> 40 years.
• Diagnosis of DM.
• Informed Consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (2)

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Bari, 70124, Italy

Location

AUSL-IRCCS di Reggio Emilia

Reggio Emilia, 42122, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sera samples

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 Design

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

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: February 5, 2025
• Study Start: June 13, 2019
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)