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Not yet recruitingNCT03938207Updated Aug 11, 2022

Dry Eye Syndrome, Healthy Control, Sjögren's Syndrome and Other Inflammation Disease in Taiwan Biobank

An observational study in Dry Eye Syndrome, Sjogren's Syndrome and Healthy Control, sponsored by Taipei Veterans General Hospital, Taiwan. Not yet recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-11.

Sponsored by Taipei Veterans General Hospital, Taiwan · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2022, 3 years 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100,000
Ages
20 Years to 75 Years
Sex
All
01

Study summary

The comprehensive analysis of health records, TCM constitution, biomarker, and whole-genome sequencing among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease in Taiwan: an integrated analysis between Taiwan Biobank and Sjögren's syndrome Database

Read the 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), healthy control (HC), and other inflammation disease (ID). In addition, we 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. We 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. It could find the pathogenesis-associated candidate genes and sites, and could apply to clinical diagnosis and drug development after verification and confirmation of efficacy. Integrated the Sjögren's syndrome (SJS) database, we could explore the comprehensive analysis among DES, HC, SJS, and ID. It would provide the evidence-base medicine in TCM in the future.

Expected Results:

  1. To evaluate the difference among questionnaire, physical examination indicators, blood biomarker, urine biomarker and biochemical biomarker for the DES, HC, and ID.
  2. To evaluate the difference among gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences for the DES, HC, and ID.
  3. To evaluate the difference among gene variation and TCM body constitution for the DES, HC, and ID.
  4. To evaluate the difference among gene variation for the DES, HC, SJS, and ID.
  5. To establish predicting modal and biomarker among DES.
02

Conditions studied

  • Dry Eye Syndrome
  • Sjogren's Syndrome
  • Healthy Control
  • Inflammation

Keywords

  • Dry eye syndrome
  • Sjögren's syndrome
  • Gene modulation
  • Xerophthalmia
  • TCM pattern
  • Inflammation
  • Healthy control
03

In context

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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.

Eligibility 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 Exclusion Criteria: NA

Inflammation disease

Inclusion Criteria:

  1. aged between 20 and 75 years
  2. Disease diagnosed with Inflammation Exclusion Criteria: NA
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Dry eye syndrome

    Dry eye syndrome patients were extracted from Taiwan Biobank.

    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 · Diagnostic Test: HLA typing · Diagnostic Test: Full-length 16S Amplicon Sequencing · Diagnostic Test: Epigenomic · Diagnostic Test: Metabolomics · Diagnostic Test: Environmental Toxic · Diagnostic Test: Medical Image

  • Health subjects

    Health subjects were extracted from Taiwan Biobank.

    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 · Diagnostic Test: HLA typing · Diagnostic Test: Full-length 16S Amplicon Sequencing · Diagnostic Test: Epigenomic · Diagnostic Test: Metabolomics · Diagnostic Test: Environmental Toxic · Diagnostic Test: Medical Image

  • 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: 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 · Diagnostic Test: HLA typing · Diagnostic Test: Full-length 16S Amplicon Sequencing · Diagnostic Test: Epigenomic · Diagnostic Test: Metabolomics · Diagnostic Test: Environmental Toxic · Diagnostic Test: Medical Image

  • other inflammation disease

    Other inflammation disease were extracted from Taiwan Biobank.

    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 · Diagnostic Test: HLA typing · Diagnostic Test: Full-length 16S Amplicon Sequencing · Diagnostic Test: Epigenomic · Diagnostic Test: Metabolomics · Diagnostic Test: Environmental Toxic · Diagnostic Test: Medical Image

Interventions

  • Diagnostic testWhole-genome genotyping

    Using Whole-genome genotyping from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease.

  • Diagnostic testWhole-genome sequencing

    Using whole-genome sequencing from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences.

  • Diagnostic testTCM pattern

    We want to use TCM pattern to investigate the difference among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease.

  • Diagnostic testDNA Exome sequencing

    The DNA of dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease will take to do the DNA Exome sequencing.

  • Diagnostic testPhysical examination indicators, blood, urine and biochemical function test

    To investigate the difference of Physical examination indicators, blood, urine and biochemical function test among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease.

  • Diagnostic testDemographics, 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 among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease.

  • Diagnostic testHLA typing

    Using HLA typing from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences.

  • Diagnostic testFull-length 16S Amplicon Sequencing

    Using Full-length 16S Amplicon Sequencing from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences.

  • Diagnostic testEpigenomic

    Using Epigenomic from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences.

  • Diagnostic testMetabolomics

    Using Metabolomics from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences.

  • Diagnostic testEnvironmental Toxic

    Using Environmental Toxic from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences.

  • Diagnostic testMedical Image

    Using Medical Image from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences.

06

What researchers measure

Primary outcomes

  1. Immunity-related gene expression

    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.

    Time frame: Five year

  2. TCM pattern

    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.

    Time frame: Five year

07

Study locations

1 site
  • Ching-Mao Chang
    Taipei, Taiwan (r.o.c.) 112, Taiwan
    • Ching-Mao Chang, M.D., Ph.D. · Contact
    • Yen-Wenn Liu, Ph.D. · Sub investigator
    • Hsueh-Ting Chu, Ph.D. · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03938207
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
May 6, 2019
Start date
Oct 1, 2022 (estimated)
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 11, 2022

Study contacts

Ching-Mao Chang, M.D., Ph.D.
Contact
magicbjp@gmail.com
88628757453 ext. 333
Ching-Mao Chang, M.D., Ph.D.
principal investigator · Taipei Veterans General Hospital, Taiwan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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