Sjogren's SyndromeNCT04978883
Interstitial Lung Diseases in Primary Sjogren's Syndrome
An observational study of Sjogren's Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Patients with pSS seen in the Division of Rheumatology, the second affiliated hospital of Zhejiang University, School of Medicine (SAHZU) during January 2016 to July 2018, were retrospectively reviewed. Characteristics were analyzed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sjogren's Syndrome
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Jul 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighty-five patients with pSS-ILD were identified, and 85 patients with pSS non-ILD were used for comparison. The average age at disease onset and median disease duration in patients with pSS-ILD were greater when compared with pSS non-ILD patients. There was no difference regarding presenting symptoms at disease onset between pSS-ILD and pSS non-ILD patients.
Who may be able to join
- All patients with pSS fulfilled the 2002 revised version of the European criteria proposed by the American-European Consensus Group
- Patient with pSS evaluated with pulmonary HRCT and/or PFTs were included in the pSS-ILD group
Who cannot join
- patients with hepatitis C infection, past head and neck radiation treatment, sarcoidosis, acquired immunodeficiency syndrome, pre-existing lymphoma, graft-versushost disease, and use of anticholinergic drugs, IgG4-related disease
- Patients with other connective tissue diseases (CTD) or other pulmonary diseases were further excluded, including those with pulmonary arterial hypertension, pulmonary infections, tuberculosis, chronic bronchitis, emphysema, asthma, chronic obstructive pulmonary disease, malignancies, pulmonary lesions related with environmental, occupational or medication exposures, or history of smoking
About this study
Official title: Characteristics of Patients With Primary Sjögren's Syndrome Associated Interstitial Lung Disease and Relevant Features of Disease Progression
Patients with pSS seen in the Division of Rheumatology, the second affiliated hospital of Zhejiang University, School of Medicine (SAHZU) during January 2016 to July 2018, were retrospectively reviewed. Characteristics were analyzed.
Read the detailed description
Patients with pSS were retrospectively reviewed, and pSS-ILD and pSS non-ILD were identified. Clinical data, laboratory parameters, pulmonary high-resolution CT (HRCT), and pulmonary function tests (PFTs) were collected. pSS-ILD patients were further categorized into subgroups according to HRCT patterns or PFTs.
- Conditions
- Sjogren's Syndrome
- Being tested
- No intervention
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| pSS-ILD | diagnosis of pSS-ILD was based on abnormal HRCT and PFTs Receives: Other: No intervention | |
| pSS non-ILD | pSS patients after exclusion of pSS-ILD and concomitant pulmonary diseases were considered as pSS non-ILD Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
observational study, data analysis to identify the risk factors of pSS-ILD
ILD progressed in 6 months from baseline
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Jan 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 170 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978883
- Sponsor's protocol ID
- 20181236FSKXJ
- Status last verified
- Jul 2021
- First submitted
- 18 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- 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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Patients With Primary Sjögren's Syndrome Associated Interstitial Lung Disease and Relevant Features of Disease Progression
- ClinicalTrials.gov ID
- NCT04978883
- Acronym / sponsor ID
- 20181236FSKXJ
- Conditions
- Sjogren's Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 27 Jul 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.
Patients with pSS seen in the Division of Rheumatology, the second affiliated hospital of Zhejiang University, School of Medicine (SAHZU) during January 2016 to July 2018, were retrospectively reviewed. Characteristics were analyzed.
Detailed description
Patients with pSS were retrospectively reviewed, and pSS-ILD and pSS non-ILD were identified. Clinical data, laboratory parameters, pulmonary high-resolution CT (HRCT), and pulmonary function tests (PFTs) were collected. pSS-ILD patients were further categorized into subgroups according to HRCT patterns or PFTs.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pSS-ILD | – | Other: No interventiondiagnosis of pSS-ILD was based on abnormal HRCT and PFTs |
| pSS non-ILD | – | Other: No interventionpSS patients after exclusion of pSS-ILD and concomitant pulmonary diseases were considered as pSS non-ILD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighty-five patients with pSS-ILD were identified, and 85 patients with pSS non-ILD were used for comparison. The average age at disease onset and median disease duration in patients with pSS-ILD were greater when compared with pSS non-ILD patients. There was no difference regarding presenting symptoms at disease onset between pSS-ILD and pSS non-ILD patients.
Key inclusion criteria (2 listed)
- All patients with pSS fulfilled the 2002 revised version of the European criteria proposed by the American-European Consensus Group
- Patient with pSS evaluated with pulmonary HRCT and/or PFTs were included in the pSS-ILD group
Key exclusion criteria (2 listed)
- patients with hepatitis C infection, past head and neck radiation treatment, sarcoidosis, acquired immunodeficiency syndrome, pre-existing lymphoma, graft-versushost disease, and use of anticholinergic drugs, IgG4-related disease
- Patients with other connective tissue diseases (CTD) or other pulmonary diseases were further excluded, including those with pulmonary arterial hypertension, pulmonary infections, tuberculosis, chronic bronchitis, emphysema, asthma, chronic obstructive pulmonary disease, malignancies, pulmonary lesions related with environmental, occupational or medication exposures, or history of smoking
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 |
|---|---|---|
| No interventionNo intervention | Other | pSS non-ILD, pSS-ILD |
Primary outcome
observational study, data analysis to identify the risk factors of pSS-ILD
Time frame: 6 months from baseline
ILD progressed in 6 months from baseline
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 27 Jul 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.
Chen study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 2 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 27 Jul 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?
observational study, data analysis to identify the risk factors of pSS-ILD (time frame: 6 months from 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 27 Jul 2021.