Antisynthetase SyndromeNCT04941547
Association Between Cancer and Anti-synthetase Syndrome
An observational study of Antisynthetase Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Among Idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. However, clinical evidences of the association of those diseases led to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antisynthetase Syndrome
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients with antisynthetase syndrome, defined by the positivity of antisynthetase antibodies and the presence of at least one clinical involvment, are included, either with or without cancer, to allow comparison of patients according to the presence of cancer.
Who may be able to join
- adult patients
- positive antisynthetase antibodies (JO-1,PL12, PL17, EJ, OJ, KS, RS, YRS)
Who cannot join
- age under 18
- opposition to data collection
- no positive antisynthetase antibodies
- absence of clinical involvment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Thomas Moulinet
Vandœuvre-lès-Nancy, Lorraine, 54500
Thomas Moulinet, 0686252853, t.moulinet@chru-nancy.fr
About this study
Official title: Association Between Cancer and Anti-synthetase Syndrome : a Multicenter Study
Among Idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. However, clinical evidences of the association of those diseases led to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions.
Read the detailed description
Idiopathic inflammatory myopathies area heterogeneous group of disease involving mainly muscles, which paraneoplastic feature has been well characterized, specifically in some subgroups such as dermatomyositis. In contrast, antisynthetase syndrome is thought to be rarely associated with cancer. However, clinical observations of the association of those diseases led us to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions, describing the type of cancer observed as well as clinical features of patients and diagnostic work-up leading to the diagnosis of cancer.
- Conditions
- Antisynthetase Syndrome
- Keywords
- cancer, idiopathic inflammatory myopathies
- Medical subject headings
- Antisynthetase syndrome, Neoplasms, Myositis
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer prevalence
prevalence of cancer among patients with antisynthetase syndrome
Measured: baseline
Secondary outcomes (2)
description of cancer type in patients with antisynthetase syndrome
description of the type and stage of cancer in patients with antisynthetase syndrome
Measured: baseline
factors associated with cancer
comparison of clinical and paraclinical features associated with cancer in patients with antisynthetase syndrome
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Apr 2021
- Primary completion31 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antisynthetase SyndromeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, CHU de Reims, University Hospital, Strasbourg, France, Hopitaux Prives de Metz, Groupe UNEOS, Centre Hospitalier Universitaire de Besancon
- Responsible party
- Sponsor
- Investigators
- Thomas Moulinet, MD, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941547
- Sponsor's protocol ID
- 2021PI055
- Status last verified
- May 2021
- First submitted
- 22 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cancer and Anti-synthetase Syndrome : a Multicenter Study
- ClinicalTrials.gov ID
- NCT04941547
- Acronym / sponsor ID
- 2021PI055
- Conditions
- Antisynthetase Syndrome
- Keywords
- cancer, idiopathic inflammatory myopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, CHU de Reims, University Hospital, Strasbourg, France, Hopitaux Prives de Metz, Groupe UNEOS, Centre Hospitalier Universitaire de Besancon
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 28 Jun 2021 (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.
Among Idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. However, clinical evidences of the association of those diseases led to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions.
Detailed description
Idiopathic inflammatory myopathies area heterogeneous group of disease involving mainly muscles, which paraneoplastic feature has been well characterized, specifically in some subgroups such as dermatomyositis. In contrast, antisynthetase syndrome is thought to be rarely associated with cancer. However, clinical observations of the association of those diseases led us to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions, describing the type of cancer observed as well as clinical features of patients and diagnostic work-up leading to the diagnosis of cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with antisynthetase syndrome, defined by the positivity of antisynthetase antibodies and the presence of at least one clinical involvment, are included, either with or without cancer, to allow comparison of patients according to the presence of cancer.
Key inclusion criteria (2 listed)
- adult patients
- positive antisynthetase antibodies (JO-1,PL12, PL17, EJ, OJ, KS, RS, YRS)
Key exclusion criteria (4 listed)
- age under 18
- opposition to data collection
- no positive antisynthetase antibodies
- absence of clinical involvment
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
cancer prevalence
Time frame: baseline
prevalence of cancer among patients with antisynthetase syndrome
2 secondary outcomes
description of cancer type in patients with antisynthetase syndrome
Time frame: baseline
factors associated with cancer
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: No
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Descartes-08 in Autoantibody Myositis
Antisynthetase Syndrome
RecruitingPhase 1
BCMA-CD19 cCAR-T for the Treatment of Refractory Inflammatory Myopathy
Inflammatory Myopathy
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A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome
Antisynthetase Syndrome, Interstitial Lung Disease (ILD)
Active, not recruitingPhase 2/3
Add-on Intravenous Immunoglobulins in Early Myositis
Inflammatory Myopathy, Idiopathic, Dermatomyositis
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.
Thomas Moulinet, MD principal investigator
CHRU de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antisynthetase Syndrome, run by Central Hospital, Nancy, France at 1 site in France.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Moulinet, MD (0686252853, t.moulinet@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cancer prevalence (time frame: baseline). 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 28 Jun 2021.