Clinical trial NCT03699228: China Health Big Data
Official title: China Nationwide Multi Center Big Data Study on the Quantitative Computed Tomography (QCT) and Health Status of Check -up Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Obesity
Liver Steatoses
Keywords: Bone mineral density, quantitative computed tomography, Osteoporosis, obesity, liver steatosis
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: Ruijin Hospital
name: Huashan Hospital
name: Henan Provincial People's Hospital
name: The Affiliated Hospital Of Guizhou Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: The First Affiliated Hospital of Zhengzhou University
name: First Affiliated Hospital Xi'an Jiaotong University
name: The renmin hospital of wuhan university
name: Nanjing BenQ Hospital
name: China-Japan Friendship Hospital
name: xinan hospital
name: Wu Hu Yijishan hospital
name: The fifth affiliated hospital of zhong shan university
First posted: 2018-10-09
Enrollment: 30000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General health check population

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The spinal volumetric bone mineral density (vBMD)
timeFrame: 2 year
Secondary outcomes:
measure: The visceral adipose tissue (VAT)
timeFrame: 2 year
measure: Liver fat
timeFrame: 2 years
Other outcomes:
Locations:
city: Wu Hu
country: China
facility: Wu Hu Yijishan Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Jishuitan hospital
state: Beijing
city: Guiyang
country: China
facility: The first affiliated hospital of Guiyang Medical University
state: Guizhou
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou University
state: Henan
city: Shanghai
country: China
facility: Hua Shan hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ruijin hospital
state: Shanghai
Study officials:
affiliation: Beijing Jishuitan Hospital
name: xiaoguang cheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General PLA hospital
name: qiang zeng
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.