Clinical trial NCT02693496: Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research
Official title: Mobile Lung Nodule Observatory for Worldwide, Evidenced - Based Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solitary Pulmonary Nodule
Keywords: ResearchKit
CT screening
Early Diagnosis
Lung Cancer
Lead sponsor: Chinese Alliance Against Lung Cancer
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 10,000 patients will participate in this research program, in 100 different medical institutions.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the diagnostic accuracy among different type of lung nodules.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Union Hospital
city: Beijing
country: China
facility: General Hospital of PLA
city: Cangzhou
country: China
facility: Hebei Pronvince Cangzhou City People's Hospital
city: Changsha
country: China
facility: Xiaya Hospital Central South Unversity
city: Chaoyang
country: China
facility: Anhui Province Chaoyang Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: No.1 Hospital Chongqing Medical University
city: Chongqing
country: China
facility: Western East Hospital No. 3 PLA Medical University
city: Dalian
country: China
facility: No. 2 Hospital Dalian Medical University
city: Guizhou
country: China
facility: Guizhou Province People's Hospital
city: Hangzhou
country: China
facility: International Hospital Zhejiang University
city: Hangzhou
country: China
facility: No. 1 Hospital Zhejiang University Medical College
city: Kunming
country: China
facility: Yunnan Province Cancer Hospital
city: Liaocheng
country: China
facility: Shandong Province Liaocheng City People's Hospital
city: Quanzhou
country: China
facility: No. 2 Hospital Fujian Medical University
city: Quzhou
country: China
facility: Kecheng District Hospital
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
city: Shanghai
country: China
facility: Minhang District Hospital Fudan University
city: Shanghai
country: China
facility: Putuo District Central Hospital Shanghai Chinese Medical University
city: Shanghai
country: China
facility: Ruici Clinic
city: Tianjin
country: China
facility: No. 2 Hospital Tianjin Chinese Medical University
city: Weifang
country: China
facility: Weifang City No.2 People's Hospital
city: Wudang
country: China
facility: Wudang Hospital Guiyang Medical College
city: Wuhu
country: China
facility: Wuhu City No. 2 Hopsital
city: Wuxi
country: China
facility: No. 5 Wuxi People's Hospital
city: Xiamen
country: China
facility: Xiamen City No.3 People's Hospital
city: Xian
country: China
facility: Xining Hospital No.4 PLA University
city: Yantai
country: China
facility: Yantai City Taishan Hopsital
city: Zhengzhou
country: China
facility: Henan Province People's Hospital
city: Zhengzhou
country: China
facility: No. 1 Hospital Zhengzhou University
city: Zibo
country: China
facility: Shandong Pronvince Zibo City Official Hospital
city: Zibo
country: China
facility: Shandong Province Linzi District Hospital
city: Zigong
country: China
facility: Sichuan Province Zigong City No. 1 Hospital
city: Zunyi
country: China
facility: Guizhou Province Zunyi Medical College Hospital
Study officials:
affiliation: Chinese Alliance Against Lung Cancer
name: Chunxue Bai, M.D, Ph.D
role: STUDY_CHAIR
References:
citation: Yang DW, Zhang Y, Hong QY, Hu J, Li C, Pan BS, Wang Q, Ding FH, Ou JX, Liu FL, Zhang D, Zhou JB, Song YL, Bai CX. Role of a serum-based biomarker panel in the early diagnosis of lung cancer for a cohort of high-risk patients. Cancer. 2015 Sep 1;121 Suppl 17:3113-21. doi: 10.1002/cncr.29551.
citation: Gould MK, Donington J, Lynch WR, Mazzone PJ, Midthun DE, Naidich DP, Wiener RS. Evaluation of individuals with pulmonary nodules: when is it 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):e93S-e120S. doi: 10.1378/chest.12-2351.