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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03938207

Enrollment

100000

Registered

2019-05-06

Start date

2022-10-01

Completion date

2027-12-31

Last updated

2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief 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

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.

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Immunity-related gene expression	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.
TCM pattern	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.

Countries

Taiwan

Contacts

Primary ContactChing-Mao Chang, M.D., Ph.D.

magicbjp@gmail.com88628757453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026