Interstitial Lung Diseases in Primary Sjogren's Syndrome

NCT ID: NCT04978883

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-07-31

Brief Summary

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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

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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

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Sjogren's Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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pSS non-ILD

pSS patients after exclusion of pSS-ILD and concomitant pulmonary diseases were considered as pSS non-ILD

No intervention

Intervention Type OTHER

No intervention

pSS-ILD

diagnosis of pSS-ILD was based on abnormal HRCT and PFTs

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other Identifiers

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20181236FSKXJ

Identifier Type: -

Identifier Source: org_study_id

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