Brief Summary

To explore the association among gene, TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis with the DNA Exome sequencing tools for Sjögren's syndrome

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Apr 2019

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

9 months study duration

Study Start

First participant enrolled

April 1, 2019

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed

10 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed

13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed

Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

April 22, 2019

Last Update Submit

May 2, 2019

Conditions

Sjögren's Syndrome

Keywords

Immune regulationSjögren's syndromeGene modulationTraditional Chinese Medicine patternTraditional Chinese Medicine tongue diagnosisTraditional Chinese Medicine pulse diagnosisProteomicsOral microbiome

Outcome Measures

Primary Outcomes (7)

Immunity-related gene expression
To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control. DNA exome combine the GATK (Genome Analysis Toolkit) is a tool for detecting the ratio of immunity-related gene expression.
One year
TCM pattern
To evaluate the difference of TCM pattern between Sjögren's syndrome and healthy control. TCM pattern is a tool for detecting the constitution.
One year
TCM tongue diagnosis
To evaluate the difference of TCM tongue diagnosis between Sjögren's syndrome and healthy control. TCM tongue diagnosis is a tool for detecting tongue expression.
One year
TCM pulse diagnosis
To evaluate the difference of TCM pulse diagnosis between Sjögren's syndrome and healthy control. TCM pulse diagnosis is a tool for detecting pulse of radial artery.
One year
Heart rate variability (HRV)
To evaluate the difference of Heart rate variability (HRV) between Sjögren's syndrome and healthy control. HRV is a tool for detecting the ratio between High-frequency (HF) activity and low-frequency (LF) activity.
One year
Immunity-related proteomics expression
To evaluate the proteomics for the Sjögren's syndrome and healthy control. Proteomics is a tool for detecting the ratio of immunity-related proteomics expression.
One year
Immunity-related microbiome expression
To evaluate the oral microbiome for the Sjögren's syndrome and healthy control. Oral microbiome is a tool for detecting the ratio of immunity-related microbiome expression.
One year

Study Arms (2)

Sjögren's syndrome

Sjögren's syndrome patients were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) primary or secondary SS; (2) aged between 20 and 75 years; (3) fulfilled the 2002 American-European Consensus Criteria for SS (AECG); (4) had no abnormal findings of immune, liver, kidney, or blood function evaluations. And the exclusion criteria were: (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition; (2) pregnancy or breastfeeding; or (3) steroid pulse therapy within three months prior to the commencement of our study.

Diagnostic Test: DNA Exome sequencingDiagnostic Test: Oral microbiomeDiagnostic Test: ProteomicsDiagnostic Test: RNA sequencingDiagnostic Test: CytokineDiagnostic Test: Traditional Chinese Medicine patternDiagnostic Test: Traditional Chinese Medicine tongue diagnosisDiagnostic Test: Traditional Chinese Medicine pulse diagnosisDiagnostic Test: Heart rate variabilityDiagnostic Test: Schirmer's testDiagnostic Test: Blood function test, liver function test, kidney function test, and immune function test

Health subjects

Health subjects were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) aged between 41 and 63 years (which the age could match the SS patients enrolling in the SS-1 trial); (2) had no chronic inflammatory illness. And the exclusion criteria were: (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition; (2) pregnancy or breastfeeding; (3) abnormal findings of immune, liver, kidney, or blood function evaluations; (4) total sleeping time insufficiency less than 6 hours before one day of enrollment; (5) ever took the conventional medicine or hormone within one month; (6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.

Diagnostic Test: DNA Exome sequencingDiagnostic Test: Oral microbiomeDiagnostic Test: ProteomicsDiagnostic Test: RNA sequencingDiagnostic Test: CytokineDiagnostic Test: Traditional Chinese Medicine patternDiagnostic Test: Traditional Chinese Medicine tongue diagnosisDiagnostic Test: Traditional Chinese Medicine pulse diagnosisDiagnostic Test: Heart rate variabilityDiagnostic Test: Blood function test, liver function test, kidney function test, and immune function test

Interventions

DNA Exome sequencingDIAGNOSTIC_TEST

The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.