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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Taiwan Biobank Among Dry Eye Syndrome, Healthy Control in Taiwan

Clinicaltrials.gov identifier NCT03938207

Recruitment Status Active, not recruiting

First Posted May 6, 2019

Last update posted May 6, 2019

Study Description

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:Sjogren's Syndrome
    Dry Eye Syndrome
  • Intervention/Treatment: 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
  • Phase: N/A
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

Study Design
  • 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 2019
  • Estimated Primary Completion Date: May 2019
  • Estimated Study Completion Date: December 2023
Groups and Cohorts
Groups/Cohorts 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
Outcome Measures
  • 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.

Eligibility Criteria
  • Ages Eligible for Study: 20 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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

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

More Information
  • 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
  • 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
    Gene modulation
    TCM pattern
    Sjögren's syndrome
    Xerophthalmia
  • Additional relevant MeSH terms: Syndrome
    Sjogren's Syndrome
    Keratoconjunctivitis Sicca
    Dry Eye Syndromes