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Trial record 6 of 17 for:    "Connective Tissue Disease" | "Ethanol"

DNA Exome Sequencing TCM for Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT03935373
Recruitment Status : Active, not recruiting
First Posted : May 2, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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

Condition or disease Intervention/treatment
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 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


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.



Biospecimen Retention:   Samples With DNA
  1. The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.
  2. The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.
  3. The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.
  4. The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.
  5. The plasma of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935373


Locations
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Taiwan
Ching-Mao Chang
Taipei, Taiwan (r.o.c.), Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Ching-Mao Chang, M.D., Ph.D. Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03935373     History of Changes
Other Study ID Numbers: 2017-09-006C#3
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Immune regulation
Sjögren's syndrome
Gene modulation
Traditional Chinese Medicine pattern
Traditional Chinese Medicine tongue diagnosis
Traditional Chinese Medicine pulse diagnosis
Proteomics
Oral microbiome

Additional relevant MeSH terms:
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Connective Tissue Diseases
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases