Clinical trial NCT03487952: Evaluation of Lung Nodule Detection With Artificial Intelligence Assisted Computed Tomography in North China
Official title: Evaluation of Lung Nodule and Lung Cancer Detection With Artificial Intelligence Assisted Computed Tomography Among People Living in North China: a Prospective Single-arm Multicentre Study of Screening
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solitary Pulmonary Nodule
Multiple Pulmonary Nodules
Keywords: Lung nodule
Computed tomography
Artificial intelligence
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Lu'an Municipal Hospital
name: North China Petroleum Bureau General Hospital
First posted: 2018-04-04
Enrollment: 5000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People aged over 40, routinely conducting chest LDCT scan yearly in designated hospital of North China in at least the past 4 years up to December 2017, with acceptable physical conditions are eligible.

Brief summary: Lung cancer is one of the leading cause of cancer related death in China. Lung cancer screening with low-dose computed tomography was considered as a better approach than radiography. However, the role of Lung cancer screening with Low-dose CT (LDCT) among Chinese people remains unclear. With rapid development of artificial intelligence (AI),the application of AI in detection and diagnosis of diseases has become research focus. Moreover, patients' psychological status also plays an important role in diagnosis and treatment.

This study focuses on detection and natural history management of lung nodule and lung cancer with AI assisted chest CT among people living in North China, and aims to investigate epidemiological results, patients' medical records and social psychological status.

Detailed description: Lu'an Municipal Hospital and North China Petroleum Bureau General Hospital initialed the lung cancer screening by LDCT a few years ago. People living in North China who are administrated by these hospitals routinely took a chest CT every year. This study is to the best of our knowledge the first one designed to combine lung nodule and lung cancer screening with the application of artificial intelligence in China.

Methods: Firstly, the study acquires epidemiological, medical information and psychological status of people recruited, and investigates the data acquired from past several years of CT scans using AI to develop a model for lung nodule detection. Secondly, evaluating the performance of models and apply it to analyse the CT scans from the North China population recruited. Thirdly, improving the model and adding function for lung nodule prediction of natural history and probability of malignancy.

Aims: To depict the epidemiological results about the incidence of lung nodules and lung cancer in North China population; To evaluate association between people 's epidemiological, medical and psychological profiles and incidence, diagnosis and treatment of lung nodule; To develop an artificial intelligence assisted lung nodule diagnosis and management software to assist strategies of CT screening.

Eligibility criteria: Inclusion Criteria:

* Aged 40 years or older
* Routinely conducting chest CT scan at a low-dose setting (120kVp, 40-80mA, slice thickness of 1.25 mm or less) yearly in Lu'an Municipal Hospital and North China Petroleum Bureau General Hospital in at least the past 4 years up to December 2017, willing to continue routine yearly LDCT scan.
* Chest CT data are available for DICOM format.
* Signed Informed Consent Form.

Exclusion Criteria:

* Pregnant woman and the disabled
* Past thoracic surgery history, except for diagnostic thoracoscopy
* Poor physical status without sufficient respiratory reserve to undergo lobectomy if necessary
* Shortened life expectancy less than 10 years
* Malignant tumor history within the past 5 years, except for the following conditions: cured skin basal cell carcinoma, superficial bladder carcinoma. and uterine cervix cancer in situ.
* Past history of interstitial lung disease, pulmonary bulla and lung tuberculosis.
* Other circumstances which is deemed inappropriate for enrollment by the researchers.

Primary outcomes:
measure: Detection rate of lung nodule
timeFrame: 3 months
measure: Profile of detected lung nodule
timeFrame: 3 months
Secondary outcomes:
measure: Sensitivity in the detection of clinically actionable lung nodules
timeFrame: 3 months
measure: Growth of lung nodule
timeFrame: 3 years
measure: Anxiety and depression level
timeFrame: 3 months
measure: Life quality and health status
timeFrame: 3 months
measure: Lung cancer detection rate
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Jun J Wang, MM
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wiener RS, Gould MK, Woloshin S, Schwartz LM, Clark JA. What do you mean, a spot?: A qualitative analysis of patients' reactions to discussions with their physicians about pulmonary nodules. Chest. 2013 Mar;143(3):672-677. doi: 10.1378/chest.12-1095.
citation: Harris RP, Sheridan SL, Lewis CL, Barclay C, Vu MB, Kistler CE, Golin CE, DeFrank JT, Brewer NT. The harms of screening: a proposed taxonomy and application to lung cancer screening. JAMA Intern Med. 2014 Feb 1;174(2):281-5. doi: 10.1001/jamainternmed.2013.12745.