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Набор скоро начнётся NCT03938207

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

— Наблюдательное Dry Eye Syndrome Sjogren's Syndrome Healthy Control Inflammation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Whole-genome genotyping, Whole-genome sequencing, TCM pattern, DNA Exome sequencing.
Кому может быть актуально
Состояния в реестре: Dry Eye Syndrome, Sjogren's Syndrome, Healthy Control, Inflammation. Базовые параметры: 20 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Immunity-related gene expression [Срок оценки: Five year]
  • TCM pattern [Срок оценки: Five year]

Критерии участия

Sjögren's syndrome

Критерии включения

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

Dry eye syndrome

Критерии включения

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

Inflammation disease

Критерии включения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Тайвань · 1 центр
  • Ching-Mao Chang — Taipei

Публикации

  • 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 40724666

Идентификаторы

NCT: NCT03938207 · 2018-04-009ACF

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗