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Natural History and Risk Factors of TAO

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ClinicalTrials.gov Identifier: NCT03515863
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Yingfeng Zheng, Sun Yat-sen University

Tracking Information
First Submitted Date April 23, 2018
First Posted Date May 4, 2018
Last Update Posted Date September 23, 2019
Actual Study Start Date May 15, 2018
Estimated Primary Completion Date May 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2018)
Genetic risk factors of TAO predisposition [ Time Frame: 1 year ]
Genetic risk factors of TAO are identified by pathogenic gene screening using the whole-genome sequencing of peripheral blood cells.
Original Primary Outcome Measures
 (submitted: April 23, 2018)
Genetic risk factors of TAO predisposition [ Time Frame: 1 year, 2 years, 3 years ]
Genetic risk factors of TAO are identified by pathogenic gene screening using the whole-genome sequencing of peripheral blood cells.
Change History Complete list of historical versions of study NCT03515863 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 18, 2018)
Cellular biomarkers for risk of TAO [ Time Frame: 1 year ]
Cellular biomarkers for risk of TAO are identified by transcriptomics and mass cytometry
Original Secondary Outcome Measures
 (submitted: April 23, 2018)
Cellular biomarkers for risk of TAO [ Time Frame: 1 year, 2 years, 3 years ]
Cellular biomarkers for risk of TAO are identified by transcriptomics and mass cytometry
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural History and Risk Factors of TAO
Official Title Natural History and Genetic Risk Factors of Thyroid Associated Ophthalmopathy (TAO)
Brief Summary The aim of this study is to complete the identification of genetic factors predisposing to thyroid associated ophthalmopathy (TAO) by constituting a cohort of 400 Grave's patients with or without ocular signs.
Detailed Description Graves' disease (GD) is a common autoimmune condition, and its ocular condition is known as thyroid-associated ophthalmopathy (TAO). There is considerable evidence that both genetic and environmental factors are involved in the development of TAO. We conduct a study of 400 Grave's patients, with or without TAO, and obtain the following data: genetic tests, ocular imaging and life style information. Genetic tests are obtained by collection of blood samples for DNA extraction, whole-genome sequencing, and identification of cellular biomarkers, using transcriptomics and mass cytometry. Ocular imaging data are collected from Orbit MRI examination. Life style data are collected using a standardized questionnaire.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

TAO Patients:

Patients who are diagnosed as Grave's disease and TAO are enrolled into the study from 2 clinical centers. This diagnosis is made according to classical criteria of TAO, including thyroid function testing, ocular examination and orbit MRI examination.

Control:

Patients who are diagnosed as Grave's disease but without ocular signs are enrolled into the study from 2 clinical centers. This diagnosis of Grave's disease is made according to classical criteria including thyroid function testing. Ocular signs are excluded by routine ocular examination and orbit MRI examination.

Condition Thyroid Associated Ophthalmopathy
Intervention
  • Genetic: DNA extraction and genetic characterization
    Collection of blood samples for DNA extraction and genetic characterization using whole-genome sequencing, and for identification of cellular biomarkers using transcriptomics and mass cytometry.
  • Device: Orbit MRI examination
    Orbit MRI examination is performed to confirm the diagnosis of TAO
  • Other: Collection of life style data
    Collection of life style data using quality of life questionnaire
Study Groups/Cohorts
  • Grave's disease with TAO
    Patients with Grave's disease and TAO
    Interventions:
    • Genetic: DNA extraction and genetic characterization
    • Device: Orbit MRI examination
    • Other: Collection of life style data
  • Grave's disease without TAO
    Patients with Grave's disease but without TAO
    Interventions:
    • Genetic: DNA extraction and genetic characterization
    • Device: Orbit MRI examination
    • Other: Collection of life style data
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2018)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 9, 2022
Estimated Primary Completion Date May 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients of Grave's disease with the history of more than 1 years
  2. Informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study

Exclusion Criteria:

  1. Pregnancy (positive test) or lactation
  2. Participating in another simultaneous medical investigation or clinical trial within 3 months
  3. Having received cellular therapy
  4. With a history of psychotropic drugs abuse
  5. With a history of mental disorder
  6. With a history of malignant tumor
  7. Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yingfeng Zheng +8613922286455 zhyfeng@mail.sysu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03515863
Other Study ID Numbers 2017KYPJ123
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Yingfeng Zheng, Sun Yat-sen University
Study Sponsor Sun Yat-sen University
Collaborators Not Provided
Investigators Not Provided
PRS Account Sun Yat-sen University
Verification Date September 2019