NCT03938207

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
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Whole-genome genotyping	Using Whole-genome genotyping from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease.
DIAGNOSTIC_TEST	Whole-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_TEST	TCM 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_TEST	DNA 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_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 dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease.
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 among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease.
DIAGNOSTIC_TEST	HLA 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_TEST	Full-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_TEST	Epigenomic	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_TEST	Metabolomics	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_TEST	Environmental 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_TEST	Medical 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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2022-12-01
• Completion: 2027-12-31
• First posted: 2019-05-06
• Last updated: 2022-08-11

Locations

1 site across 1 country: Taiwan