Adult Onset Still DiseaseAOSD-DIFNCT04750863
Evaluation of Adult Onset Still Disease Classification Criteria and Differential Diagnosis at Eighteen Months of Follow-up
An observational study of Adult Onset Still Disease, run by Central Hospital, Nancy, France.
Trial summary
Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Onset Still Disease
- What is being tested?
- diagnosis criteria performance
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2010to 1 Feb 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with suspected adult onset still disease with at least 18 months of follow-up.
Who may be able to join
- adults
- with glycosylated ferritin dosage for suspected adult onset still disease
- with at least 18 month of follow-up
Who cannot join
- known infectious disease
- known cancer
- known active connective tissue disease or vasculitis
About this study
Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up of patients. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.
Read the detailed description
Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Other conditions such as cancer, infection or other inflammatory disease might mimick its symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up after an initial diagnosis of AOSD. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.
- Conditions
- Adult Onset Still Disease
- Being tested
- diagnosis criteria performance
- Keywords
- adult onset still disease, differential diagnosis, diagnosis performance
- Medical subject headings
- Still's Disease, Adult-Onset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis criteria performanceOther
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis performance of Yamaguchi and Fautrel criteria at 18 months of follow-up
Sensitivity, Specificity, positive predictive value, negative predictive value
Measured: after 18 months of follow-up
Secondary outcomes (2)
description of differential diagnosis mimicking adult onset still disease
Measured: after 18 months of follow-up
identifying factors associated with the occurence of a differential diagnosis during follow-up
Measured: after 18 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start15 Jul 2010
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Onset Still DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750863
- Sponsor's protocol ID
- 2021PI001
- Acronym
- AOSD-DIF
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 11 Feb 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 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adult Onset Still Disease Classification Criteria and Differential Diagnosis at Eighteen Months of Follow-up
- ClinicalTrials.gov ID
- NCT04750863
- Acronym / sponsor ID
- AOSD-DIF / 2021PI001
- Conditions
- Adult Onset Still Disease
- Keywords
- adult onset still disease, differential diagnosis, diagnosis performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Jul 2010 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 11 Feb 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.
Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up of patients. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.
Detailed description
Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Other conditions such as cancer, infection or other inflammatory disease might mimick its symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up after an initial diagnosis of AOSD. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with suspected adult onset still disease with at least 18 months of follow-up.
Key inclusion criteria (3 listed)
- adults
- with glycosylated ferritin dosage for suspected adult onset still disease
- with at least 18 month of follow-up
Key exclusion criteria (3 listed)
- known infectious disease
- known cancer
- known active connective tissue disease or vasculitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnosis criteria performance | Other | – |
Primary outcome
diagnosis performance of Yamaguchi and Fautrel criteria at 18 months of follow-up
Time frame: after 18 months of follow-up
Sensitivity, Specificity, positive predictive value, negative predictive value
2 secondary outcomes
description of differential diagnosis mimicking adult onset still disease
Time frame: after 18 months of follow-up
identifying factors associated with the occurence of a differential diagnosis during follow-up
Time frame: after 18 months of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Onset Still Disease, run by Central Hospital, Nancy, 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 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: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
diagnosis performance of Yamaguchi and Fautrel criteria at 18 months of follow-up (time frame: after 18 months of follow-up). 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 11 Feb 2021.