Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research

Solitary Pulmonary Nodule Clinical Trial

— mLOWER  

Official title:

Mobile Lung Nodule Observatory for Worldwide, Evidenced - Based Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02693496
• Other study ID #: CAALC-002-mLOWER
• Status: Recruiting
• Start date: October 2015
• Est. completion date: October 2025

Study information

• Verified date: August 2018
• Source: Chinese Alliance Against Lung Cancer
• Contact: Chunxue Bai, M.D, Ph.D
• Phone: +86 186-2117-0011
• Email: bai.chunxue[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Solitary Pulmonary Nodule

Intervention

Other:
• Installation or registration of smartphone application
Completed the installation and registration of mobile terminal software online

Locations

Country	Name	City	State
China	Beijing Union Hospital	Beijing
China	General Hospital of PLA	Beijing
China	Hebei Pronvince Cangzhou City People's Hospital	Cangzhou
China	Xiaya Hospital Central South Unversity	Changsha
China	Anhui Province Chaoyang Hospital	Chaoyang
China	West China Hospital Sichuan University	Chengdu
China	No.1 Hospital Chongqing Medical University	Chongqing
China	Western East Hospital No. 3 PLA Medical University	Chongqing
China	No. 2 Hospital Dalian Medical University	Dalian
China	Guizhou Province People's Hospital	Guizhou
China	International Hospital Zhejiang University	Hangzhou
China	No. 1 Hospital Zhejiang University Medical College	Hangzhou
China	Yunnan Province Cancer Hospital	Kunming
China	Shandong Province Liaocheng City People's Hospital	Liaocheng
China	No. 2 Hospital Fujian Medical University	Quanzhou
China	Kecheng District Hospital	Quzhou
China	Minhang District Hospital Fudan University	Shanghai
China	Putuo District Central Hospital Shanghai Chinese Medical University	Shanghai
China	Ruici Clinic	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai
China	No. 2 Hospital Tianjin Chinese Medical University	Tianjin
China	Weifang City No.2 People's Hospital	Weifang
China	Wudang Hospital Guiyang Medical College	Wudang
China	Wuhu City No. 2 Hopsital	Wuhu
China	No. 5 Wuxi People's Hospital	Wuxi
China	Xiamen City No.3 People's Hospital	Xiamen
China	Xining Hospital No.4 PLA University	Xian
China	Yantai City Taishan Hopsital	Yantai
China	Henan Province People's Hospital	Zhengzhou
China	No. 1 Hospital Zhengzhou University	Zhengzhou
China	Shandong Pronvince Zibo City Official Hospital	Zibo
China	Shandong Province Linzi District Hospital	Zibo
China	Sichuan Province Zigong City No. 1 Hospital	Zigong
China	Guizhou Province Zunyi Medical College Hospital	Zunyi

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Alliance Against Lung Cancer

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   JINYUN Doctor - Apple App Store
•   Official website of Chinese Alliance Against Lung Cancer