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

Not yet recruiting

• Conditions: Dry Eye Syndrome; Sjogren's Syndrome; Healthy Control; Inflammation
• Interventions: 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

• Registration Number: NCT03938207
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-11
• Study Start: 2022-10-01
• Primary Completion: 2022-12-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dry eye syndrome	Physical examination indicators, blood, urine and biochemical function test	Dry eye syndrome patients were extracted from Taiwan Biobank.
Dry eye syndrome	Whole-genome sequencing	Dry eye syndrome patients were extracted from Taiwan Biobank.
Dry eye syndrome	DNA Exome sequencing	Dry eye syndrome patients were extracted from Taiwan Biobank.
Dry eye syndrome	HLA typing	Dry eye syndrome patients were extracted from Taiwan Biobank.
Dry eye syndrome	Epigenomic	Dry eye syndrome patients were extracted from Taiwan Biobank.
Health subjects	Physical examination indicators, blood, urine and biochemical function test	Health subjects were extracted from Taiwan Biobank.
Sjögren's syndrome	Whole-genome genotyping	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)
Dry eye syndrome	Whole-genome genotyping	Dry eye syndrome patients were extracted from Taiwan Biobank.
Dry eye syndrome	Metabolomics	Dry eye syndrome patients were extracted from Taiwan Biobank.
Health subjects	Whole-genome genotyping	Health subjects were extracted from Taiwan Biobank.
Health subjects	TCM pattern	Health subjects were extracted from Taiwan Biobank.
Dry eye syndrome	TCM pattern	Dry eye syndrome patients were extracted from Taiwan Biobank.
Health subjects	Whole-genome sequencing	Health subjects were extracted from Taiwan Biobank.
Health subjects	Full-length 16S Amplicon Sequencing	Health subjects were extracted from Taiwan Biobank.
Health subjects	Metabolomics	Health subjects were extracted from Taiwan Biobank.
Health subjects	Medical Image	Health subjects were extracted from Taiwan Biobank.
Sjögren's syndrome	HLA typing	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)
other inflammation disease	DNA Exome sequencing	Other inflammation disease were extracted from Taiwan Biobank.
other inflammation disease	Metabolomics	Other inflammation disease were extracted from Taiwan Biobank.
Dry eye syndrome	Demographics, personal health behavior, living environment, dietary status, family history	Dry eye syndrome patients were extracted from Taiwan Biobank.
Dry eye syndrome	Environmental Toxic	Dry eye syndrome patients were extracted from Taiwan Biobank.
Dry eye syndrome	Medical Image	Dry eye syndrome patients were extracted from Taiwan Biobank.
Health subjects	Demographics, personal health behavior, living environment, dietary status, family history	Health subjects were extracted from Taiwan Biobank.
Health subjects	HLA typing	Health subjects were extracted from Taiwan Biobank.
Health subjects	Environmental Toxic	Health subjects were extracted from Taiwan Biobank.
Dry eye syndrome	Full-length 16S Amplicon Sequencing	Dry eye syndrome patients were extracted from Taiwan Biobank.
Health subjects	DNA Exome sequencing	Health subjects were extracted from Taiwan Biobank.
Health subjects	Epigenomic	Health subjects were extracted from Taiwan Biobank.
Sjögren's syndrome	Physical examination indicators, blood, urine and biochemical function test	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)
other inflammation disease	Demographics, personal health behavior, living environment, dietary status, family history	Other inflammation disease were extracted from Taiwan Biobank.
other inflammation disease	HLA typing	Other inflammation disease were extracted from Taiwan Biobank.
other inflammation disease	Epigenomic	Other inflammation disease were extracted from Taiwan Biobank.
other inflammation disease	Medical Image	Other inflammation disease were extracted from Taiwan Biobank.
Sjögren's syndrome	Whole-genome sequencing	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)
Sjögren's syndrome	TCM pattern	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)
Sjögren's syndrome	Full-length 16S Amplicon Sequencing	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)
Sjögren's syndrome	Environmental Toxic	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)
Sjögren's syndrome	Medical Image	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)
Sjögren's syndrome	DNA Exome sequencing	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)
Sjögren's syndrome	Epigenomic	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)
other inflammation disease	Whole-genome genotyping	Other inflammation disease were extracted from Taiwan Biobank.
other inflammation disease	TCM pattern	Other inflammation disease were extracted from Taiwan Biobank.
other inflammation disease	Environmental Toxic	Other inflammation disease were extracted from Taiwan Biobank.
Sjögren's syndrome	Demographics, personal health behavior, living environment, dietary status, family history	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)
Sjögren's syndrome	Metabolomics	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)
other inflammation disease	Whole-genome sequencing	Other inflammation disease were extracted from Taiwan Biobank.
other inflammation disease	Physical examination indicators, blood, urine and biochemical function test	Other inflammation disease were extracted from Taiwan Biobank.
other inflammation disease	Full-length 16S Amplicon Sequencing	Other inflammation disease were extracted from Taiwan Biobank.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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