Sjögren's SyndromeNCT03935373
DNA Exome Sequencing TCM for Sjögren's Syndrome
An observational study of Sjögren's Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjögren's Syndrome
- What is being tested?
- DNA Exome sequencing, Oral microbiome and Proteomics
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 31 Dec 2019
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- (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.
- (1) aged 20 and 75 years
- (2) had no chronic inflammatory illness.
Who cannot join
- (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
- (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
- (2) pregnancy or breastfeeding
Show all 10Show fewer
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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:
- To evaluate the difference among TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and HRV for the Sjögren's syndrome and healthy control.
- To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control.
- To evaluate the proteomics for the Sjögren's syndrome and healthy control.
- To evaluate the oral microbiome for the Sjögren's syndrome and healthy control.
- 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
- Conditions
- Sjögren's Syndrome
- Being tested
- DNA Exome sequencing, Oral microbiome, Proteomics, RNA sequencing, Cytokine
- Keywords
- Immune regulation, Sjögren's syndrome, Gene modulation, Traditional Chinese Medicine pattern, Traditional Chinese Medicine tongue diagnosis, Traditional Chinese Medicine pulse diagnosis, Proteomics, Oral microbiome
- 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.
DNA Exome sequencingDiagnostic test
The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.
Oral microbiomeDiagnostic test
The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.
ProteomicsDiagnostic test
The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.
RNA sequencingDiagnostic test
The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.
CytokineDiagnostic test
The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.
Traditional Chinese Medicine patternDiagnostic test
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.
Traditional Chinese Medicine tongue diagnosisDiagnostic test
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.
Traditional Chinese Medicine pulse diagnosisDiagnostic test
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.
Heart rate variabilityDiagnostic test
Sjögren's syndrome patients and health subjects will take the heart rate variability.
Schirmer's testDiagnostic test
Sjögren's syndrome patients will take the Schirmer's test.
Blood function test, liver function test, kidney function test, and immune function testDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 | |
| 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. Receives: 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: Blood function test, liver function test, kidney function test, and immune function test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Apr 2019
- Primary completion15 May 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ching-Mao Chang, M.D., Ph.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935373
- Sponsor's protocol ID
- 2017-09-006C#3
- Status last verified
- May 2019
- First submitted
- 22 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- 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 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03935373
- Acronym / sponsor ID
- 2017-09-006C#3
- Conditions
- Sjögren's Syndrome
- Keywords
- Immune regulation, Sjögren's syndrome, Gene modulation, Traditional Chinese Medicine pattern, Traditional Chinese Medicine tongue diagnosis, Traditional Chinese Medicine pulse diagnosis, Proteomics, Oral microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 May 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 May 2019 (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.
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
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:
- To evaluate the difference among TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and HRV for the Sjögren's syndrome and healthy control.
- To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control.
- To evaluate the proteomics for the Sjögren's syndrome and healthy control.
- To evaluate the oral microbiome for the Sjögren's syndrome and healthy control.
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sjögren's syndrome | – | 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 testSjögren'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 | – | 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: Blood function test, liver function test, kidney function test, and immune function testHealth 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- (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.
- (1) aged 20 and 75 years
Key exclusion criteria (10 listed)
- (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
- (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
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 |
|---|---|---|
| DNA Exome sequencingThe DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing. | Diagnostic test | Health subjects, Sjögren's syndrome |
| Oral microbiomeThe saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome. | Diagnostic test | Health subjects, Sjögren's syndrome |
| ProteomicsThe protein of Sjögren's syndrome patients and health subjects will take to do the proteomics. | Diagnostic test | Health subjects, Sjögren's syndrome |
| RNA sequencingThe RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing. | Diagnostic test | Health subjects, Sjögren's syndrome |
| CytokineThe serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future. | Diagnostic test | Health subjects, Sjögren's syndrome |
| Traditional Chinese Medicine patternSjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern. | Diagnostic test | Health subjects, Sjögren's syndrome |
| Traditional Chinese Medicine tongue diagnosisSjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis. | Diagnostic test | Health subjects, Sjögren's syndrome |
| Traditional Chinese Medicine pulse diagnosisSjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis. | Diagnostic test | Health subjects, Sjögren's syndrome |
| Heart rate variabilitySjögren's syndrome patients and health subjects will take the heart rate variability. | Diagnostic test | Health subjects, Sjögren's syndrome |
| Schirmer's testSjögren's syndrome patients will take the Schirmer's test. | Diagnostic test | Sjögren's syndrome |
| Blood function test, liver function test, kidney function test, and immune function testSjögren'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) | Diagnostic test | Health subjects, Sjögren's syndrome |
Primary outcome
Immunity-related gene expression
Time frame: One year
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.
TCM pattern
Time frame: One year
To evaluate the difference of TCM pattern between Sjögren's syndrome and healthy control. TCM pattern is a tool for detecting the constitution.
TCM tongue diagnosis
Time frame: One year
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.
TCM pulse diagnosis
Time frame: One year
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.
Heart rate variability (HRV)
Time frame: One year
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.
Immunity-related proteomics expression
Time frame: One year
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.
Immunity-related microbiome expression
Time frame: One year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- 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.
Ching-Mao Chang, M.D., Ph.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren's Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Immunity-related gene expression (time frame: One year). The study lists 7 primary outcomes in all. 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 6 May 2019.