DNA Exome Sequencing TCM for Sjögren's Syndrome

Using the DNA Exome Sequencing Tools to Explore the Association Among Gene Sequence, TCM Pattern, TCM Tongue Diagnosis and TCM Pulse Diagnosis for Sjögren's Syndrome

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

Study Overview

• Status: Unknown
• Conditions: Sjögren's Syndrome
• Intervention / Treatment: Diagnostic test: DNA Exome sequencing; Diagnostic test: Oral microbiome; Diagnostic test: Proteomics; Diagnostic test: RNA sequencing; Diagnostic test: Cytokine; Diagnostic test: Traditional Chinese Medicine pattern; Diagnostic test: Traditional Chinese Medicine tongue diagnosis; Diagnostic test: Traditional Chinese Medicine pulse diagnosis; Diagnostic test: Heart rate variability; Diagnostic test: Schirmer's test; Diagnostic test: Blood function test, liver function test, kidney function test, and immune function test

Detailed Description

Objective: 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

Method:

This study wants to establish the reference value of DNA gene variants of healthy control for comparing with the Sjögren's syndrome subjects. And the investigators want to use the DNA Exome sequencing tools, proteomics and oral microbiome to explore the association of gene expression between at least 30 Sjögren's syndrome subjects and at least 10 healthy control subjects. Finally, the investigators also analyze the association among gene expression, proteomics and oral microbiome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and heart rate variability (HRV) for this purpose.

Expected Results:

1. To evaluate the difference among TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and HRV for the Sjögren's syndrome and healthy control.
2. To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control.
3. To evaluate the proteomics for the Sjögren's syndrome and healthy control.
4. To evaluate the oral microbiome for the Sjögren's syndrome and healthy control.
5. To evaluate the association among the immunity-related gene expression, SSA, SSB and RF.

Keyword: Sjögren's syndrome, Immune regulation, Gene modulation, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, proteomics, oral microbiome

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan (r.o.c.)
    • Taipei, Taiwan (r.o.c.), Taiwan, 112
      • Ching-Mao Chang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Sjögren's syndrome patients and Health subjects were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital.

Description

Sjögren's syndrome

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.

Exclusion Criteria:

• (1)a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
• (2) pregnancy or breastfeeding
• (3) steroid pulse therapy within three months prior to the commencement of our study.

Health Subjects

Inclusion Criteria:

• (1) aged 20 and 75 years
• (2) had no chronic inflammatory illness.

Exclusion Criteria:

• (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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 sequencing; The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.; Diagnostic test: Oral microbiome; The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.; Diagnostic test: Proteomics; The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.; Diagnostic test: RNA sequencing; The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.; Diagnostic test: Cytokine; The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.; Diagnostic test: Traditional Chinese Medicine pattern; Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.; Diagnostic test: Traditional Chinese Medicine tongue diagnosis; Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.; Diagnostic test: Traditional Chinese Medicine pulse diagnosis; Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.; Diagnostic test: Heart rate variability; Sjögren's syndrome patients and health subjects will take the heart rate variability.; Diagnostic test: Schirmer's test; Sjögren's syndrome patients will take the Schirmer's test.; Diagnostic test: Blood function test, liver function test, kidney function test, and immune function test; Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)
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 sequencing; The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.; Diagnostic test: Oral microbiome; The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.; Diagnostic test: Proteomics; The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.; Diagnostic test: RNA sequencing; The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.; Diagnostic test: Cytokine; The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.; Diagnostic test: Traditional Chinese Medicine pattern; Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.; Diagnostic test: Traditional Chinese Medicine tongue diagnosis; Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.; Diagnostic test: Traditional Chinese Medicine pulse diagnosis; Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.; Diagnostic test: Heart rate variability; Sjögren's syndrome patients and health subjects will take the heart rate variability.; Diagnostic test: Blood function test, liver function test, kidney function test, and immune function test; Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Ching-Mao Chang, M.D., Ph.D., Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): May 15, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Proteomics; Sjögren's syndrome; Oral microbiome; Gene modulation; Immune regulation; Traditional Chinese Medicine pattern; Traditional Chinese Medicine tongue diagnosis; Traditional Chinese Medicine pulse diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: 2017-09-006C#3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No