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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 20 to 75 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Study population: Health Subjects Inclusion Criteria: 1. aged 20 and 75 years 2. had no chronic inflammatory illness. Exclusion Criteria: 1. a history of alcohol abuse, diabetes mellitus, or major life-threatening condition 2. pregnancy or breastfeeding 3. abnormal findings of immune, liver, kidney, or blood function evaluations 4. total sleeping time insufficiency less than 6 hours before one day of enrollment 5. ever took the conventional medicine or hormone within one month 6. ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Dry Eye Syndrome, Sjogren's Syndrome, Healthy Control, Inflammation

Being tested

Whole-genome genotyping, Whole-genome sequencing, TCM pattern, DNA Exome sequencing, Physical examination indicators, blood, urine and biochemical function test

Keywords

Dry eye syndrome, Sjögren's syndrome, Gene modulation, Xerophthalmia, TCM pattern, Inflammation, Healthy control

Medical subject headings

Dry Eye Syndromes, Sjogren's Syndrome, Inflammation, Xerophthalmia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Whole-genome genotypingDiagnostic test

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

• Whole-genome sequencingDiagnostic 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 patternDiagnostic 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 sequencingDiagnostic 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 testDiagnostic 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 historyDiagnostic 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 typingDiagnostic 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 SequencingDiagnostic 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.

• EpigenomicDiagnostic 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.

• MetabolomicsDiagnostic 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 ToxicDiagnostic 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 ImageDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Five year

2. 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.

   Measured: Five year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 May 2019
2. Study start1 Oct 2022 (estimated)
3. Primary completion1 Dec 2022 (estimated)
4. Study completion31 Dec 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
• More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.