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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03938207
Other study ID # 2018-04-009ACF
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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