NCT03515863

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

April 23, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

April 23, 2018

Last Update Submit

September 20, 2019

Conditions

Thyroid Associated Ophthalmopathy

Outcome Measures

Primary Outcomes (1)

  • Genetic risk factors of TAO predisposition

    Genetic risk factors of TAO are identified by pathogenic gene screening using the whole-genome sequencing of peripheral blood cells.

    1 year

Secondary Outcomes (1)

  • Cellular biomarkers for risk of TAO

    1 year

Study Arms (2)

Grave's disease with TAO

Patients with Grave's disease and TAO

Genetic: DNA extraction and genetic characterizationDevice: Orbit MRI examinationOther: Collection of life style data

Grave's disease without TAO

Patients with Grave's disease but without TAO

Genetic: DNA extraction and genetic characterizationDevice: Orbit MRI examinationOther: Collection of life style data

Interventions

DNA extraction and genetic characterizationGENETIC

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.

Grave's disease with TAOGrave's disease without TAO
Orbit MRI examinationDEVICE

Orbit MRI examination is performed to confirm the diagnosis of TAO

Grave's disease with TAOGrave's disease without TAO
Collection of life style dataOTHER

Collection of life style data using quality of life questionnaire

Grave's disease with TAOGrave's disease without TAO

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients of Grave's disease with the history of more than 1 years
  • 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

You may not qualify if:

  • Pregnancy (positive test) or lactation
  • Participating in another simultaneous medical investigation or clinical trial within 3 months
  • Having received cellular therapy
  • With a history of psychotropic drugs abuse
  • With a history of mental disorder
  • With a history of malignant tumor
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, China

RECRUITING

the First People's Hospital of Zhaoqing

Zhaoqing, China

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Yingfeng Zheng

CONTACT

+8613922286455zhyfeng@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical investigator

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 4, 2018

Study Start

May 15, 2018

Primary Completion

May 9, 2021

Study Completion

May 9, 2022

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations

CN(2)