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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03938207
• Other study ID #: 2018-04-009ACF
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Ching-Mao Chang, M.D., Ph.D.
• Phone: 88628757453
• Email: magicbjp[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Healthy Control
• Inflammation
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome
• Syndrome

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Ching-Mao Chang	Taipei	Taiwan (r.o.c.)

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Five year
Primary	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.	Five year