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NCT Number: NCT03938207

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

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

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Key information

Conditions

Dry Eye Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Conjunctival Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Healthy Control Immune System Diseases Inflammation Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerophthalmia Xerostomia

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ching-Mao Chang

Taipei, Taiwan (r.o.c.), 112, Taiwan

Location contact

Ching-Mao Chang, M.D., Ph.D.

CONTACT

Hsueh-Ting Chu, Ph.D.

SUB_INVESTIGATOR

Yen-Wenn Liu, Ph.D.

SUB_INVESTIGATOR

About this study

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:

  • To evaluate the difference among questionnaire, physical examination indicators, blood biomarker, urine biomarker and biochemical biomarker for the DES, HC, and ID.
  • 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.
  • To evaluate the difference among gene variation and TCM body constitution for the DES, HC, and ID.
  • To evaluate the difference among gene variation for the DES, HC, SJS, and ID.
  • To establish predicting modal and biomarker among DES.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Sjögren's syndrome

Inclusion criteria

  • aged between 20 and 75 years
  • fulfilled the 2002 American-European Consensus Criteria for SS (AECG) Exclusion Criteria: NA

Dry eye syndrome

Inclusion criteria

  • aged between 20 and 75 years
  • Schirmer's test less than 10 mm/5 min Exclusion Criteria: NA

Inflammation disease

Inclusion criteria

  • aged between 20 and 75 years
  • Disease diagnosed with Inflammation Exclusion Criteria: NA

Treatment and study plan

Whole-genome genotyping

Diagnostic Test

Using Whole-genome genotyping from Taiwan Biobank among dry eye syndrome, healthy control, Sjögren's syndrome and other inflammation disease.

Whole-genome sequencing

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic 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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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.

Primary outcomes

  1. Immunity-related gene expression

    Time frame: 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.

  2. TCM pattern

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ching-Mao Chang, M.D., Ph.D.

CONTACT

[email protected]

88628757453 ext. 333

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2027
First posted
May 6, 2019
Registry last updated
Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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