Evaluation of Lung Nodule Detection With Artificial Intelligence Assisted Computed Tomography in North China
NCT ID: NCT03487952
Last Updated: 2018-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5000 participants
OBSERVATIONAL
2018-04-30
2021-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LDCT screening group
People receive questionnaire administration at baseline, then subsequent yearly chest LDCT scan and follow up.
Questionnaire Administration
Subjects will be asked to complete an additional detailed questionnaire regarding personal information, smoking history, medical history, their diet and lifestyle habits, family history of malignant neoplasm, any past or current environmental exposures and psychological status.
Interventions
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Questionnaire Administration
Subjects will be asked to complete an additional detailed questionnaire regarding personal information, smoking history, medical history, their diet and lifestyle habits, family history of malignant neoplasm, any past or current environmental exposures and psychological status.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Lu'an Municipal Hospital
OTHER
North China Petroleum Bureau General Hospital
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Jun Wang
Principal Investigator, Clinical Professor
Principal Investigators
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Jun J Wang, MM
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Central Contacts
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References
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Field JK, Oudkerk M, Pedersen JH, Duffy SW. Prospects for population screening and diagnosis of lung cancer. Lancet. 2013 Aug 24;382(9893):732-41. doi: 10.1016/S0140-6736(13)61614-1.
Silva M, Pastorino U, Sverzellati N. Lung cancer screening with low-dose CT in Europe: strength and weakness of diverse independent screening trials. Clin Radiol. 2017 May;72(5):389-400. doi: 10.1016/j.crad.2016.12.021. Epub 2017 Feb 4.
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
Detterbeck FC, Mazzone PJ, Naidich DP, Bach PB. Screening for lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e78S-e92S. doi: 10.1378/chest.12-2350.
Baldwin DR, Callister ME; Guideline Development Group. The British Thoracic Society guidelines on the investigation and management of pulmonary nodules. Thorax. 2015 Aug;70(8):794-8. doi: 10.1136/thoraxjnl-2015-207221. Epub 2015 Jul 1.
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.
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.
Other Identifiers
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NCLUNG
Identifier Type: -
Identifier Source: org_study_id
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