NCT03938207

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Oct 2022Dec 2027

First Submitted

Initial submission to the registry

April 22, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
3.4 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

April 22, 2019

Last Update Submit

August 9, 2022

Conditions

Dry Eye SyndromeSjogren's SyndromeHealthy ControlInflammation

Keywords

Dry eye syndromeSjögren's syndromeGene modulationXerophthalmiaTCM patternInflammationHealthy control

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (4)

Dry eye syndrome

Dry eye syndrome patients were extracted from Taiwan Biobank.

Diagnostic Test: Whole-genome genotypingDiagnostic Test: Whole-genome sequencingDiagnostic Test: TCM patternDiagnostic Test: DNA Exome sequencingDiagnostic Test: Physical examination indicators, blood, urine and biochemical function testDiagnostic Test: Demographics, personal health behavior, living environment, dietary status, family historyDiagnostic Test: HLA typingDiagnostic Test: Full-length 16S Amplicon SequencingDiagnostic Test: EpigenomicDiagnostic Test: MetabolomicsDiagnostic Test: Environmental ToxicDiagnostic Test: Medical Image

Health subjects

Health subjects were extracted from Taiwan Biobank.

Diagnostic Test: Whole-genome genotypingDiagnostic Test: Whole-genome sequencingDiagnostic Test: TCM patternDiagnostic Test: DNA Exome sequencingDiagnostic Test: Physical examination indicators, blood, urine and biochemical function testDiagnostic Test: Demographics, personal health behavior, living environment, dietary status, family historyDiagnostic Test: HLA typingDiagnostic Test: Full-length 16S Amplicon SequencingDiagnostic Test: EpigenomicDiagnostic Test: MetabolomicsDiagnostic Test: Environmental ToxicDiagnostic Test: Medical Image

Sjögren's syndrome

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)

Diagnostic Test: Whole-genome genotypingDiagnostic Test: Whole-genome sequencingDiagnostic Test: TCM patternDiagnostic Test: DNA Exome sequencingDiagnostic Test: Physical examination indicators, blood, urine and biochemical function testDiagnostic Test: Demographics, personal health behavior, living environment, dietary status, family historyDiagnostic Test: HLA typingDiagnostic Test: Full-length 16S Amplicon SequencingDiagnostic Test: EpigenomicDiagnostic Test: MetabolomicsDiagnostic Test: Environmental ToxicDiagnostic Test: Medical Image

other inflammation disease

Other inflammation disease were extracted from Taiwan Biobank.

Diagnostic Test: Whole-genome genotypingDiagnostic Test: Whole-genome sequencingDiagnostic Test: TCM patternDiagnostic Test: DNA Exome sequencingDiagnostic Test: Physical examination indicators, blood, urine and biochemical function testDiagnostic Test: Demographics, personal health behavior, living environment, dietary status, family historyDiagnostic Test: HLA typingDiagnostic Test: Full-length 16S Amplicon SequencingDiagnostic Test: EpigenomicDiagnostic Test: MetabolomicsDiagnostic Test: Environmental ToxicDiagnostic Test: Medical Image

Interventions

Whole-genome genotypingDIAGNOSTIC_TEST

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

Dry eye syndromeHealth subjectsSjögren's syndromeother 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.

Dry eye syndromeHealth subjectsSjögren's syndromeother inflammation disease
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.

Dry eye syndromeHealth subjectsSjögren's syndromeother 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.

Dry eye syndromeHealth subjectsSjögren's syndromeother inflammation disease
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.

Dry eye syndromeHealth subjectsSjögren's syndromeother 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.

Dry eye syndromeHealth subjectsSjögren's syndromeother 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.

Dry eye syndromeHealth subjectsSjögren's syndromeother inflammation disease
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.

Dry eye syndromeHealth subjectsSjögren's syndromeother inflammation disease
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.

Dry eye syndromeHealth subjectsSjögren's syndromeother inflammation disease
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.

Dry eye syndromeHealth subjectsSjögren's syndromeother inflammation disease
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.

Dry eye syndromeHealth subjectsSjögren's syndromeother inflammation disease
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.

Dry eye syndromeHealth subjectsSjögren's syndromeother inflammation disease

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • aged between 20 and 75 years

You may not qualify if:

  • Dry eye syndrome
  • aged between 20 and 75 years
  • Inflammation disease
  • aged between 20 and 75 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ching-Mao Chang

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

Location

Related Publications (1)

  • Huang PY, Chen CH, Chiu YF, Lin HC, Chang CM. Dietary Habits, TCM Constitutions, and Obesity: Investigating the Protective Effects of Vegetarian Dietary Patterns in Taiwan. Healthcare (Basel). 2025 Jul 8;13(14):1641. doi: 10.3390/healthcare13141641.

    PMID: 40724666DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The DNA of Sjögren's syndrome patients, dry eye syndrome patients, other inflammation disease, and health subjects will take to do the DNA Exome sequencing. The saliva of Sjögren's syndrome patients, other inflammation disease, and health subjects will take to do the oral microbiome. The protein of Sjögren's syndrome patients, other inflammation disease, and health subjects will take to do the proteomics. The RNA of Sjögren's syndrome patients, dry eye syndrome patients, other inflammation disease, and health subjects will store to do the RNA sequencing. The plasma of Sjögren's syndrome patients, dry eye syndrome patients, other inflammation disease, and health subjects will store to do the cytokine detection in the future.

MeSH Terms

Conditions

Dry Eye SyndromesSjogren's SyndromeInflammationXerophthalmia

Interventions

Blood Specimen CollectionUrinationNutritional StatusMedical History TakingHistocompatibility Testing

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsConjunctival Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsImmunologic TestsImmunologic Techniques

Study Officials

  • Ching-Mao Chang, M.D., Ph.D.

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

88628757453magicbjp@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2019

First Posted

May 6, 2019

Study Start

October 1, 2022

Primary Completion

December 1, 2022

Study Completion (Estimated)

December 31, 2027

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)