China Health Big Data (China biobank)

China Nationwide Multi Center Big Data Study on the Quantitative Computed Tomography (QCT) and Health Status of Check -up Population

In this nationwide multi center study the investigators combine the low dose chest CT scan data with QCT technology, to measure the BMD of spine, VAT and liver fat in the health check subjects. The aim of this study is to evaluate the performance of QCT in the health check field, and further to evaluate the prevalence of osteoporosis, obesity and liver steatosis in health check population across China.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Osteoporosis; Liver Steatoses

Detailed Description

Low dose Chest CT scan is the standard for lung cancer in the health check center in China. Quantitative computed tomography (QCT) is utilizing the CT raw data to measure the bone mineral density (BMD), the visceral fat (VAT) and liver fat content in human, which can be widely used in the diagnosis of osteoporosis, the assessment of obesity and liver steatosis. In this nationwide multi center study the investigators combine the low dose chest CT scan data with QCT technology, to measure the BMD of spine, VAT and liver fat in the health check subjects. This study is to evaluate the performance of QCT in the health check field, and further to evaluate the prevalence of osteoporosis, obesity and liver steatosis in health check population across China.

• Study Type: Observational
• Enrollment (Anticipated): 30000

Contacts and Locations

• Study Contact: Name: xiaoxia fu, md; Phone Number: 0086-13683132746

Study Locations

• China
  • Anhui
    • Wu Hu, Anhui, China, 100035
      • Recruiting
      • Wu Hu Yijishan Hospital
      • Contact: xiaojun zha; Phone Number: 008613705533568
  • Beijing
    • Beijing, Beijing, China, 100035
      • Recruiting
      • Beijing Jishuitan hospital
      • Contact: Kai Li, PhD; Phone Number: 008615801633664
      • Principal Investigator: Ling Wang, MD
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • The first affiliated hospital of Guiyang Medical University
      • Contact: Xia Du, MD; Phone Number: 008613765071289
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Yan Wu, MD; Phone Number: 008613803843588
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Hua Shan Hospital
      • Contact: Shuang chen; Phone Number: 008613601717952
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Ruijin Hospital
      • Contact: Yong Lu, MD; Phone Number: 008613701995934

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

General health check population

Description

Inclusion Criteria:

health check subjects 30-90 years old low dose chest CT scan

Exclusion Criteria:

pregnant women metal implant in the CT scan area

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The spinal volumetric bone mineral density (vBMD)	The volumetric bone mineral density of L1-2 measured by QCT	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The visceral adipose tissue (VAT)	The visceral adipose tissue (VAT) measured by quantitative computed tomography (QCT)	2 year
Liver fat	Liver fat measurement by quantitative computed tomography (QCT)	2 years

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital
• Collaborators: Chinese PLA General Hospital; Huashan Hospital; First Affiliated Hospital Xi'an Jiaotong University; Ruijin Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The First Affiliated Hospital of Zhengzhou University; China-Japan Friendship Hospital; Henan Provincial People's Hospital; The Affiliated Hospital Of Guizhou Medical University; The renmin hospital of wuhan university; Nanjing BenQ Hospital; xinan hospital; Wu Hu Yijishan hospital; The fifth affiliated hospital of zhong shan university
• Investigators: Principal Investigator: xiaoguang cheng, MD, Beijing Jishuitan hospital; Principal Investigator: qiang zeng, General PLA hospital

Publications and helpful links

General Publications

• Cheng X, Zhao K, Zha X, Du X, Li Y, Chen S, Wu Y, Li S, Lu Y, Zhang Y, Xiao X, Li Y, Ma X, Gong X, Chen W, Yang Y, Jiao J, Chen B, Lv Y, Gao J, Hong G, Pan Y, Yan Y, Qi H, Ran L, Zhai J, Wang L, Li K, Fu H, Wu J, Liu S, Blake GM, Pickhardt PJ, Ma Y, Fu X, Dong S, Zeng Q, Guo Z, Hind K, Engelke K, Tian W; China Health Big Data (China Biobank) project investigators. Opportunistic Screening Using Low-Dose CT and the Prevalence of Osteoporosis in China: A Nationwide, Multicenter Study. J Bone Miner Res. 2021 Mar;36(3):427-435. doi: 10.1002/jbmr.4187. Epub 2020 Nov 4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: October 5, 2018
• First Submitted That Met QC Criteria: October 5, 2018
• First Posted (ACTUAL): October 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Bone mineral density, quantitative computed tomography, Osteoporosis, obesity, liver steatosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Liver Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Fatty Liver; Osteoporosis
• Other Study ID Numbers: jst2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No