NCT04941547

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 28, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

June 22, 2021

Last Update Submit

June 22, 2021

Conditions

Antisynthetase Syndrome

Keywords

canceridiopathic inflammatory myopathies

Outcome Measures

Primary Outcomes (1)

  • cancer prevalence

    prevalence of cancer among patients with antisynthetase syndrome

    baseline

Secondary Outcomes (2)

  • description of cancer type in patients with antisynthetase syndrome

    baseline

  • factors associated with cancer

    baseline

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Moulinet

Vandœuvre-lès-Nancy, Lorraine, 54500, France

RECRUITING

MeSH Terms

Conditions

Antisynthetase syndromeNeoplasmsMyositis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Thomas Moulinet, MD

    CHRU de Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Moulinet, MD

CONTACT

0686252853t.moulinet@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 28, 2021

Study Start

April 1, 2021

Primary Completion

July 31, 2021

Study Completion

September 1, 2021

Last Updated

June 28, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)