Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research

Study Overview
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Brief Summary
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Patients with lung nodules may develop a variety of potentially severe symptoms. These symptoms may impact a patient's quality of life and lead to difficult treatment. Through this research program, the investigators want to understand the pathogenesis of the changes of these symptoms.

Detailed Description
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Lung nodules can manifest as single or multiple independent lung consolidation shadow in form of quasi-circular. These lung nodules are surrounded by normal lung tissues, and will not cause pulmonary atelectasis. In some early standards, all the quasi-circular shadows within 6cm found in lung are categorized as lung nodules. However, according to current standards, the lesion within 3cm can be identified as lung nodules. With widespread use of lung cancer CT screening, lung nodules were identified more and more frequently. What is the optimal way to manage this CT finding? Should we adopt surgical removal or just observation? An optimal solution is to determine a clearly defined standard of care that is easy to learn. We propose a method called three plus two. The 'Three' is a three-step testing method, and the 'Two' means two alternative solutions. Three-step testing method includes collecting medical history, non-invasive examination, and invasive examination. The two alternative solutions are surgical removal and follow-up observation. We have independently developed an application based on a smartphone platform. This platform will provide a novel evidence-based research method for observing the dynamic evolution of the lung nodules in patients. There have been no prior studies about managing this CT scan finding, either in China or internationally.

Official Title
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Mobile Lung Nodule Observatory for Worldwide, Evidenced - Based Research

Conditions
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Solitary Pulmonary Nodule

Intervention / Treatment
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* Other: Installation or registration of smartphone application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 90 There is a chest lesion less than 3cm width (examined by Thin-Section CT) The patient or his family member owns a smartphone Signed informed consent Completed the installation and registration of mobile terminal software online Willing to complete a 10-year period of follow-up Exclusion Criteria: Not equipped with a smartphone Cannot complete the installation or registration of smartphone application software online Received prior chemotherapy medications for lung cancer or received lung surgical removal treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Installation or registration of smartphone application|Completed the installation and registration of mobile terminal software online|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the diagnostic accuracy among different type of lung nodules. | Utilizing the professional statistical software (SPSS 15.0), through T-test, Mann-Whitney U test, and analyzing the receiver operating characteristic (ROC) curve, to compare the diagnostic accuracy among different type of lung nodules. A p<0.05 cutoff will be the standard used to determine statistical significance. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ResearchKit, CT screening, Early Diagnosis, Lung Cancer