DermatomyositisMIOSURFACENCT06808672
Biomarkers of Cancer-Associated Myositis
An observational study of Dermatomyositis, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Dermatomyositis
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 13 Jun 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with DM during rheumatologic visits of the national health system
Who may be able to join
- Age > 40 years.
- Diagnosis of DM.
- Informed Consent
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, 70124
AUSL-IRCCS di Reggio Emilia
Reggio Emilia, 42122
About this study
Official title: Plasma Membrane Antigens as Trigger in Cancer-associated Myositis
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.
Read the detailed description
Several studies have reported an association between cancers and autoimmune diseases. Mechanisms underlying this association are largely unknown, but similarity between antigens expressed by cells in tissues targeted by autoimmune reactions and cancer cells is likely one of the drivers. Moreover, chronic inflammation can favor cancer onset.
Among autoimmune diseases, dermatomyositis (DM) has the highest association with cancers. About 25% of patients with DM, over 40 years old, have cancer at the time of diagnosis or develop cancer later. Common cancers include lung, breast, colon, prostate, and ovarian cancers. DM is a systemic inflammatory disease affecting skeletal muscle, skin, and other organs (e.g., lung). Cancer risk in patients with DM is higher compared to age- and sex-matched populations, both before diagnosis and in the three years following diagnosis (standardized incidence ratio: 3.8 - 17.29).
DM is characterized by autoantibodies. Autoantibodies against transcriptional intermediary factor TIF1-gamma, nuclear matrix protein (NXP2), and SUMO1 activating enzyme (SAE1) are detected more frequently in patients with paraneoplastic DM compared to patients without cancers and healthy controls. In contrast, autoantibodies against Jo-1 are detected less frequently. However, the identification of patients with increased cancer risk remains incomplete since DM patients negative for all known autoantibodies also have an increased risk. While TIF1-gamma, NXP2, and Jo-1 are intracellular antigens, plasma membrane antigens are more likely involved in cancer-associated DM due to their accessibility to antibodies.
Immune checkpoint molecules have emerged as key regulators of the immune system, crucial for self-tolerance and immune activation. They mainly act as ligand-receptor pairs, but several undergo alternative splicing, generating soluble isoforms. The production of soluble forms of immune checkpoints in DM is scarcely known.
Autoantibodies against extracellular antigens and soluble immune checkpoints may contribute to the association between cancers and autoimmunity. Identifying circulating markers deregulated in cancer-associated DM will enable the identification of patients at risk, facilitating timely screening and interventions.
Patients with dermatomyositis (DM) have an increased risk of developing tumors, making early detection crucial due to their worse prognosis. The currently known autoantibodies, such as anti-TIF1-gamma, anti-NXP2, and anti-SAE1, fail to identify all DM patients with associated tumors. Additionally, about 35% of DM patients are negative in standard autoantibody screenings but still exhibit a higher tumor risk. So far, the identified autoantibodies in cancer-associated DM target intracellular antigens, which are unlikely to have a direct pathogenic role as they cannot bind their targets under physiological conditions. Soluble immune checkpoints are believed to mediate the relationship between DM and cancer, potentially serving as biomarkers. The study hypothesizes that autoantibodies against cell surface antigens, which are more likely to be pathogenic, may be present in tumor-associated DM. It also proposes that changes in soluble immune checkpoint levels might contribute to DM-associated tumor development and could help identify at-risk patients.
This is a prospective and retrospective study. For the prospective part, serum samples will be collected at the time of enrollment, before the initiation of chemotherapy or immunotherapy. For the retrospective part, patients enrolled in the study must have an available serum sample stored at -80°C, and potentially a muscle biopsy, fixed in formalin and embedded in paraffin, taken during the diagnostic phase.
- Conditions
- Dermatomyositis
- Keywords
- Dermatomyositis, Immune Checkpoints, Autoantibodies, Cancer Risk
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At Enrollment
Secondary outcomes (3)
Expression of autoantigens in muscle biopsy samples from DM patients and cancer samples
The expression of novel autoantigens will be tested using the immunohistochemistry technique in muscle biopsy samples from dermatomyositis (DM) patients, as well as in samples from ovarian, breast, and colon carcinomas, and normal tissues. Differences in the expression pattern of autoantigens between the DM patient samples and tumor samples will be identified
Measured: At Enrollment
Expression of autoantibodies against surface proteins in patients with dermatomyositis (DM) compared to healthy controls.
Median fluorescence intensities obtained after incubation of live cells with sera from DM patients will be compared to those obtained with sera from healthy subjects. These measurements will determine whether there are differences in the levels of these molecules between the serum samples from DM patients and healthy subjects.
Measured: At Enrollment
Expression of soluble immune checkpoint molecules in patients with dermatomyositis (DM) compared to healthy controls.
The levels of 14 soluble immune checkpoint molecules will be compared between serum samples from DM patients and healthy subjects. These measurements will determine whether there are differences in the levels of these molecules between the serum samples from DM patients and healthy subjects.
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start13 Jun 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808672
- Sponsor's protocol ID
- 419/2019/OSS/AUSLRE
- Acronym
- MIOSURFACE
- Status last verified
- May 2026
- First submitted
- 22 Mar 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Membrane Antigens as Trigger in Cancer-associated Myositis
- ClinicalTrials.gov ID
- NCT06808672
- Acronym / sponsor ID
- MIOSURFACE / 419/2019/OSS/AUSLRE
- Conditions
- Dermatomyositis
- Keywords
- Dermatomyositis, Immune Checkpoints, Autoantibodies, Cancer Risk
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Several studies have reported an association between cancers and autoimmune diseases. Mechanisms underlying this association are largely unknown, but similarity between antigens expressed by cells in tissues targeted by autoimmune reactions and cancer cells is likely one of the drivers. Moreover, chronic inflammation can favor cancer onset.
Among autoimmune diseases, dermatomyositis (DM) has the highest association with cancers. About 25% of patients with DM, over 40 years old, have cancer at the time of diagnosis or develop cancer later. Common cancers include lung, breast, colon, prostate, and ovarian cancers. DM is a systemic inflammatory disease affecting skeletal muscle, skin, and other organs (e.g., lung). Cancer risk in patients with DM is higher compared to age- and sex-matched populations, both before diagnosis and in the three years following diagnosis (standardized incidence ratio: 3.8 - 17.29).
DM is characterized by autoantibodies. Autoantibodies against transcriptional intermediary factor TIF1-gamma, nuclear matrix protein (NXP2), and SUMO1 activating enzyme (SAE1) are detected more frequently in patients with paraneoplastic DM compared to patients without cancers and healthy controls. In contrast, autoantibodies against Jo-1 are detected less frequently. However, the identification of patients with increased cancer risk remains incomplete since DM patients negative for all known autoantibodies also have an increased risk. While TIF1-gamma, NXP2, and Jo-1 are intracellular antigens, plasma membrane antigens are more likely involved in cancer-associated DM due to their accessibility to antibodies.
Immune checkpoint molecules have emerged as key regulators of the immune system, crucial for self-tolerance and immune activation. They mainly act as ligand-receptor pairs, but several undergo alternative splicing, generating soluble isoforms. The production of soluble forms of immune checkpoints in DM is scarcely known.
Autoantibodies against extracellular antigens and soluble immune checkpoints may contribute to the association between cancers and autoimmunity. Identifying circulating markers deregulated in cancer-associated DM will enable the identification of patients at risk, facilitating timely screening and interventions.
Patients with dermatomyositis (DM) have an increased risk of developing tumors, making early detection crucial due to their worse prognosis. The currently known autoantibodies, such as anti-TIF1-gamma, anti-NXP2, and anti-SAE1, fail to identify all DM patients with associated tumors. Additionally, about 35% of DM patients are negative in standard autoantibody screenings but still exhibit a higher tumor risk. So far, the identified autoantibodies in cancer-associated DM target intracellular antigens, which are unlikely to have a direct pathogenic role as they cannot bind their targets under physiological conditions. Soluble immune checkpoints are believed to mediate the relationship between DM and cancer, potentially serving as biomarkers. The study hypothesizes that autoantibodies against cell surface antigens, which are more likely to be pathogenic, may be present in tumor-associated DM. It also proposes that changes in soluble immune checkpoint levels might contribute to DM-associated tumor development and could help identify at-risk patients.
This is a prospective and retrospective study. For the prospective part, serum samples will be collected at the time of enrollment, before the initiation of chemotherapy or immunotherapy. For the retrospective part, patients enrolled in the study must have an available serum sample stored at -80°C, and potentially a muscle biopsy, fixed in formalin and embedded in paraffin, taken during the diagnostic phase.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with DM during rheumatologic visits of the national health system
Key inclusion criteria (3 listed)
- Age > 40 years.
- Diagnosis of DM.
- Informed Consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of autoantibodies against surface proteins in patients with dermatomyositis (DM) with and without cancer.
Time frame: 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.
Time frame: 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.
3 secondary outcomes
Expression of autoantigens in muscle biopsy samples from DM patients and cancer samples
Time frame: At Enrollment
Expression of autoantibodies against surface proteins in patients with dermatomyositis (DM) compared to healthy controls.
Time frame: At Enrollment
Expression of soluble immune checkpoint molecules in patients with dermatomyositis (DM) compared to healthy controls.
Time frame: At Enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatomyositis, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of autoantibodies against surface proteins in patients with dermatomyositis (DM) with and without cancer. (time frame: At enrollement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.