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

• 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

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