Association Between Cancer and Anti-synthetase Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Antisynthetase Syndrome

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Thomas Moulinet, MD; Phone Number: 0686252853; Email: t.moulinet@chru-nancy.fr

Study Locations

• France
  • Lorraine
    • Vandoeuvre les nancy, Lorraine, France, 54500
      • Recruiting
      • Thomas Moulinet
      • Contact: Thomas Moulinet; Phone Number: 0686252853; Email: t.moulinet@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• adult patients
• positive antisynthetase antibodies (JO-1,PL12, PL17, EJ, OJ, KS, RS, YRS)

Exclusion Criteria:

• age under 18
• opposition to data collection
• no positive antisynthetase antibodies
• absence of clinical involvment

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cancer prevalence	prevalence of cancer among patients with antisynthetase syndrome	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
description of cancer type in patients with antisynthetase syndrome	description of the type and stage of cancer in patients with antisynthetase syndrome	baseline
factors associated with cancer	comparison of clinical and paraclinical features associated with cancer in patients with antisynthetase syndrome	baseline

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: University Hospital, Strasbourg, France; CHU de Reims; Centre Hospitalier Universitaire de Besancon; CHU Dijon Bourgogne; Hôpitaux Privés de Metz
• Investigators: Principal Investigator: Thomas Moulinet, MD, CHRU de Nancy

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: cancer; idiopathic inflammatory myopathies
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 2021PI055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No