Registration Study of Takayasu's Arteritis in China (TA-China)
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|ClinicalTrials.gov Identifier: NCT03199183|
Recruitment Status : Unknown
Verified January 2019 by China National Center for Cardiovascular Diseases.
Recruitment status was: Recruiting
First Posted : June 26, 2017
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment|
|Takayasu Arteritis||Radiation: PET-CT Other: laboratory biomarker analysis Genetic: genetic sequencing|
Objective: The study aims to investigate the demographic, clinical and prognostic features and to draw the diagnostic and therapeutic algorithm of Takayasu arteritis in China.
Study Type: A national, multicenter, observational, ambispective cohort study.
Study Design: The cardinal contents of this registry study are as follows:
- Select representative clinical centers through typical sampling methods and train the local investigators in basic knowledge of Takayasu arteritis. Introduce the Electronic Data Capture System and train in completing case report forms.
- Collect demographic, clinical, imaging, laboratory, diagnostic and therapeutic information of Takayasu arteritis patients hospitalized from Jan 1st 2002 to now. Build a baseline database of Takayasu arteritis patients.
- Recruit new diagnosed Takayasu arteritis patients in future 2 years from 2017 or till reaching a total of 1067 registered patients.
- Gather the 3-month, 6-month, 1-year follow up information including general, clinical, therapeutic, prognostic data of all recruits and build up the follow-up database.
- Establish bio-bank for serum/plasma, urine, stool, tissues or cells.
Data management, quality control and statistic analysis: Electronic Data Capture System has been built and the investigators will manage and analyze data in align with key indicators. The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.
Ethics: The Ethics Committee of Fuwai Hospital approved this study and following ethical supports from participating centers are required. Informed consents before patient enrollment are required.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1067 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Registration Study of Takayasu's Arteritis in China|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
All recruited Takayasu arteritis patients.
PET-CT will be proceed on the basis of clinical status and aspiration of individual patient. The imaging results will be analysed by professional radiologists.
Other: laboratory biomarker analysis
Screening of potential biomarkers related to Takayasu arteritis and verification tests will be operated.
Genetic: genetic sequencing
Genetic sequencing results will be analysed to identify susceptible alleles or single nucleotide polymorphisms of Takayasu arteritis.
- prevalence rate [ Time Frame: 1 year ]the percentage of Takayasu arteritis patients among general population (estimated) during one-year period
- survival rate or mortality rate [ Time Frame: 1 year, at 3-month interval ]the percentage of alive or dead recruits
- rehospitalization rate [ Time Frame: 1 year, at 3-month interval ]the percentage of readmission to hospitals or centers
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199183
|Contact: Luyun Fan, MD.||firstname.lastname@example.org|
|Contact: Huimin Zhang, MD.||email@example.com|
|Principal Investigator:||Huimin Zhang, MD.||Chinese Academy of Medical Sciences, Fuwai Hospital|
|Principal Investigator:||Jun Cai, MD.PhD.||Chinese Academy of Medical Sciences, Fuwai Hospital|