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

Taipei Veterans General Hospital

Status: Not yet enrolling

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

Treatments: Diagnostic Test: HLA typing; Diagnostic Test: Whole-genome sequencing; Diagnostic Test: TCM pattern; Diagnostic Test: Environmental Toxic; Diagnostic Test: Medical Image; Diagnostic Test: Metabolomics; Diagnostic Test: Demographics, personal health behavior, living environment, dietary status, family history; Diagnostic Test: DNA Exome sequencing; Diagnostic Test: Epigenomic; Diagnostic Test: Physical examination indicators, blood, urine and biochemical function test; Diagnostic Test: Full-length 16S Amplicon Sequencing; Diagnostic Test: Whole-genome genotyping

Study type: Observational

Funder types: Other

Identifiers

NCT03938207

2018-04-009ACF

Details and patient eligibility

About

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

Full 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.

Enrollment: 100,000 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 Exclusion Criteria: NA

Inflammation disease

Inclusion Criteria:

1. aged between 20 and 75 years
2. Disease diagnosed with Inflammation Exclusion Criteria: NA

Trial design

100,000 participants in 4 patient groups

Dry eye syndrome

Description:

Dry eye syndrome patients were extracted from Taiwan Biobank.

Treatment:

Diagnostic Test: Metabolomics

Diagnostic Test: Full-length 16S Amplicon Sequencing

Diagnostic Test: Environmental Toxic

Diagnostic Test: Physical examination indicators, blood, urine and biochemical function test

Diagnostic Test: Whole-genome sequencing

Diagnostic Test: Whole-genome genotyping

Diagnostic Test: Medical Image

Diagnostic Test: DNA Exome sequencing

Diagnostic Test: Epigenomic

Diagnostic Test: Demographics, personal health behavior, living environment, dietary status, family history

Diagnostic Test: TCM pattern

Diagnostic Test: HLA typing

Health subjects

Description:

Health subjects were extracted from Taiwan Biobank.

Treatment:

Diagnostic Test: Metabolomics

Diagnostic Test: Full-length 16S Amplicon Sequencing

Diagnostic Test: Environmental Toxic

Diagnostic Test: Physical examination indicators, blood, urine and biochemical function test

Diagnostic Test: Whole-genome sequencing

Diagnostic Test: Whole-genome genotyping

Diagnostic Test: Medical Image

Diagnostic Test: DNA Exome sequencing

Diagnostic Test: Epigenomic

Diagnostic Test: Demographics, personal health behavior, living environment, dietary status, family history

Diagnostic Test: TCM pattern

Diagnostic Test: HLA typing

Sjögren's syndrome

Description:

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)

Treatment:

Diagnostic Test: Metabolomics

Diagnostic Test: Full-length 16S Amplicon Sequencing

Diagnostic Test: Environmental Toxic

Diagnostic Test: Physical examination indicators, blood, urine and biochemical function test

Diagnostic Test: Whole-genome sequencing

Diagnostic Test: Whole-genome genotyping

Diagnostic Test: Medical Image

Diagnostic Test: DNA Exome sequencing

Diagnostic Test: Epigenomic

Diagnostic Test: Demographics, personal health behavior, living environment, dietary status, family history

Diagnostic Test: TCM pattern

Diagnostic Test: HLA typing

other inflammation disease

Description:

Other inflammation disease were extracted from Taiwan Biobank.

Treatment:

Diagnostic Test: Metabolomics

Diagnostic Test: Full-length 16S Amplicon Sequencing

Diagnostic Test: Environmental Toxic

Diagnostic Test: Physical examination indicators, blood, urine and biochemical function test

Diagnostic Test: Whole-genome sequencing

Diagnostic Test: Whole-genome genotyping

Diagnostic Test: Medical Image

Diagnostic Test: DNA Exome sequencing

Diagnostic Test: Epigenomic

Diagnostic Test: Demographics, personal health behavior, living environment, dietary status, family history

Diagnostic Test: TCM pattern

Diagnostic Test: HLA typing