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Taiwan Biobank Among Dry Eye Syndrome, Healthy Control in Taiwan

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ClinicalTrials.gov Identifier: NCT03938207
Recruitment Status : Active, not recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
To evaluate the difference among questionnaire, physical examination indicators, blood biomarker, urine biomarker and biochemical biomarker for the DES, HC, and SJS.

Condition or disease Intervention/treatment
Dry Eye Syndrome Sjogren's Syndrome Diagnostic Test: Whole-genome genotyping Diagnostic Test: Whole-genome sequencing Diagnostic Test: TCM pattern Diagnostic Test: DNA Exome sequencing Diagnostic Test: Physical examination indicators, blood, urine and biochemical function test Diagnostic Test: Demographics, personal health behavior, living environment, dietary status, family history

Detailed Description:

Method: This study wants to apply the dataset of health records, physical examination indicators, blood biomarker, urine biomarker, biochemical biomarker, gene sequence, and metabolome from Taiwan Biobank Database to explore the difference among dry eye syndrome (DES) and healthy control (HC). And the investigators want to investigate the difference among the demographics, personal health behavior, living environment, dietary status, family history, Traditional Chinese medicine (TCM) body constitution, hematology test, serum biochemical test, virus test, and urine test. the investigators also want to use the whole-genome genotyping, whole-genome sequencing, DNA methylation, HLA typing, and metabolome to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences; which it could find the pathogenesis-associated candidate genes and sites, and these findings also could be applied to clinical diagnosis and drug development after verification and confirmation of efficacy. Integrated the Sjögren's syndrome (SJS) database, the investigators could explore the comprehensive analysis among DES, HC, and SJS. It would provide the evidence-base medicine in TCM in the future.

Expected Results:

To evaluate the difference among questionnaire, physical examination indicators, blood biomarker, urine biomarker and biochemical biomarker for the DES and HC.

To evaluate the difference among gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences for the DES and HC.

To evaluate the difference among gene variation and TCM body constitution for the DES and HC.

To evaluate the difference among gene variation for the DES, HC, and SJS. To establish predicting modal and biomarker among DES. Keywords: Dry eye syndrome, Xerophthalmia, Gene modulation, TCM pattern, Sjögren's syndrome


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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Comprehensive Analysis of Health Records, TCM Constitution, Biomarker, and Whole-genome Sequencing Among Dry Eye Syndrome, Healthy Control and Sjögren's Syndrome in Taiwan
Actual Study Start Date : February 23, 2019
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Dry eye syndrome
Dry eye syndrome patients were extracted from Taiwan Biobank.
Diagnostic Test: Whole-genome genotyping
Using Whole-genome genotyping from Taiwan Biobank between Dry eye syndrome and healthy control.

Diagnostic Test: Whole-genome sequencing
Using whole-genome sequencing from Taiwan Biobank between Dry eye syndrome and healthy control to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences

Diagnostic Test: TCM pattern
We want to use TCM pattern to investigate the difference among Sjögren's syndrome, Dry eye syndrome and healthy subjects

Diagnostic Test: DNA Exome sequencing
The DNA of Sjögren's syndrome, Dry eye syndrome and healthy subjects will take to do the DNA Exome sequencing.

Diagnostic Test: Physical examination indicators, blood, urine and biochemical function test
To investigate the difference of Physical examination indicators, blood, urine and biochemical function test among Sjögren's syndrome, Dry eye syndrome and healthy subjects

Diagnostic Test: Demographics, personal health behavior, living environment, dietary status, family history
To investigate the difference among the demographics, personal health behavior, living environment, dietary status, family history of Dry eye syndrome and healthy subjects

Health subjects
Health subjects were extracted from Taiwan Biobank.
Diagnostic Test: Whole-genome genotyping
Using Whole-genome genotyping from Taiwan Biobank between Dry eye syndrome and healthy control.

Diagnostic Test: Whole-genome sequencing
Using whole-genome sequencing from Taiwan Biobank between Dry eye syndrome and healthy control to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences

Diagnostic Test: TCM pattern
We want to use TCM pattern to investigate the difference among Sjögren's syndrome, Dry eye syndrome and healthy subjects

Diagnostic Test: DNA Exome sequencing
The DNA of Sjögren's syndrome, Dry eye syndrome and healthy subjects will take to do the DNA Exome sequencing.

Diagnostic Test: Physical examination indicators, blood, urine and biochemical function test
To investigate the difference of Physical examination indicators, blood, urine and biochemical function test among Sjögren's syndrome, Dry eye syndrome and healthy subjects

Diagnostic Test: Demographics, personal health behavior, living environment, dietary status, family history
To investigate the difference among the demographics, personal health behavior, living environment, dietary status, family history of Dry eye syndrome and healthy subjects

Sjögren's syndrome
Sjogren'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) aged between 20 and 75 years; (2) fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
Diagnostic Test: TCM pattern
We want to use TCM pattern to investigate the difference among Sjögren's syndrome, Dry eye syndrome and healthy subjects

Diagnostic Test: DNA Exome sequencing
The DNA of Sjögren's syndrome, Dry eye syndrome and healthy subjects will take to do the DNA Exome sequencing.

Diagnostic Test: Physical examination indicators, blood, urine and biochemical function test
To investigate the difference of Physical examination indicators, blood, urine and biochemical function test among Sjögren's syndrome, Dry eye syndrome and healthy subjects

Diagnostic Test: Demographics, personal health behavior, living environment, dietary status, family history
To investigate the difference among the demographics, personal health behavior, living environment, dietary status, family history of Dry eye syndrome and healthy subjects




Primary Outcome Measures :
  1. Immunity-related gene expression [ Time Frame: Five year ]

    To evaluate the immunity-related gene expression for Dry eye syndrome, 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: Five year ]

    To evaluate the difference of TCM pattern between Dry eye syndrome, Sjögren's syndrome and healthy control.

    TCM pattern is a tool for detecting the constitution.



Biospecimen Retention:   Samples With DNA

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

The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.

The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.

The RNA of Sjögren's syndrome patients, dry eye syndrome patients, and health subjects will store to do the RNA sequencing.

The plasma of Sjögren's syndrome patients, dry eye syndrome patients, and health subjects will store to do the cytokine detection in the future.



Information from the National Library of Medicine

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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

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.
Criteria

Sjögren's syndrome

Inclusion Criteria:

  1. aged between 20 and 75 years
  2. fulfilled the 2002 American-European Consensus Criteria for SS (AECG) Exclusion Criteria: NA

Dry eye syndrome

Inclusion Criteria:

  1. aged between 20 and 75 years
  2. Schirmer's test less than 10 mm/5 min

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): NCT03938207


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: NCT03938207     History of Changes
Other Study ID Numbers: 2018-04-009ACF
First Posted: May 6, 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:
Dry eye syndrome
Sjögren's syndrome
Gene modulation
Xerophthalmia
TCM pattern

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