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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
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:
Keyword: Sjögren's syndrome, Immune regulation, Gene modulation, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, proteomics, oral microbiome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA Exome sequencing | Diagnostic Test | The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing. |
|
| 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 |
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Sjögren's syndrome
Inclusion Criteria:
Exclusion Criteria:
Health Subjects
Inclusion Criteria:
Exclusion Criteria:
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Sjögren's syndrome patients and Health subjects were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Ching-Mao Chang, M.D., Ph.D. | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ching-Mao Chang | Taipei | Taiwan (r.o.c.) | 112 | Taiwan |
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| Oral microbiome | Diagnostic Test | The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome. |
|
| Proteomics | Diagnostic Test | The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics. |
|
| RNA sequencing | Diagnostic Test | The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing. |
|
| Cytokine | Diagnostic Test | The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future. |
|
| Traditional Chinese Medicine pattern | Diagnostic Test | Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern. |
|
| Traditional Chinese Medicine tongue diagnosis | Diagnostic Test | Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis. |
|
| Traditional Chinese Medicine pulse diagnosis | Diagnostic Test | Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis. |
|
| Heart rate variability | Diagnostic Test | Sjögren's syndrome patients and health subjects will take the heart rate variability. |
|
| Schirmer's test | Diagnostic Test | Sjögren's syndrome patients will take the Schirmer's test. |
|
| Blood function test, liver function test, kidney function test, and immune function test | Diagnostic 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) |
|
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 |
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D064307 | Microbiota |
| D001483 | Base Sequence |
| D058408 | Th1-Th2 Balance |
| D008111 | Liver Function Tests |
| D007677 | Kidney Function Tests |
| ID | Term |
|---|---|
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
| D015394 | Molecular Structure |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D055633 | Immune System Phenomena |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
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