mLOWER: Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research

Sponsor

Chinese Alliance Against Lung Cancer (Other)

Overall Status

Recruiting

CT.gov ID

NCT02693496

Collaborator

(none)

10,000

Enrollment

Locations

120

Duration (Months)

294.1

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solitary Pulmonary Nodule	Other: Installation or registration of smartphone application

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Mobile Lung Nodule Observatory for Worldwide, Evidenced - Based Research

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Outcome Measures

Primary Outcome Measures

To compare the diagnostic accuracy among different type of lung nodules. [10 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Beijing Union Hospital	Beijing	China
2	General Hospital of PLA	Beijing	China
3	Hebei Pronvince Cangzhou City People's Hospital	Cangzhou	China
4	Xiaya Hospital Central South Unversity	Changsha	China
5	Anhui Province Chaoyang Hospital	Chaoyang	China
6	West China Hospital Sichuan University	Chengdu	China
7	No.1 Hospital Chongqing Medical University	Chongqing	China
8	Western East Hospital No. 3 PLA Medical University	Chongqing	China
9	No. 2 Hospital Dalian Medical University	Dalian	China
10	Guizhou Province People's Hospital	Guizhou	China
11	International Hospital Zhejiang University	Hangzhou	China
12	No. 1 Hospital Zhejiang University Medical College	Hangzhou	China
13	Yunnan Province Cancer Hospital	Kunming	China
14	Shandong Province Liaocheng City People's Hospital	Liaocheng	China
15	No. 2 Hospital Fujian Medical University	Quanzhou	China
16	Kecheng District Hospital	Quzhou	China
17	Shanghai Zhongshan Hospital	Shanghai	China	200032
18	Minhang District Hospital Fudan University	Shanghai	China
19	Putuo District Central Hospital Shanghai Chinese Medical University	Shanghai	China
20	Ruici Clinic	Shanghai	China
21	No. 2 Hospital Tianjin Chinese Medical University	Tianjin	China
22	Weifang City No.2 People's Hospital	Weifang	China
23	Wudang Hospital Guiyang Medical College	Wudang	China
24	Wuhu City No. 2 Hopsital	Wuhu	China
25	No. 5 Wuxi People's Hospital	Wuxi	China
26	Xiamen City No.3 People's Hospital	Xiamen	China
27	Xining Hospital No.4 PLA University	Xian	China
28	Yantai City Taishan Hopsital	Yantai	China
29	Henan Province People's Hospital	Zhengzhou	China
30	No. 1 Hospital Zhengzhou University	Zhengzhou	China
31	Shandong Pronvince Zibo City Official Hospital	Zibo	China
32	Shandong Province Linzi District Hospital	Zibo	China
33	Sichuan Province Zigong City No. 1 Hospital	Zigong	China
34	Guizhou Province Zunyi Medical College Hospital	Zunyi	China