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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02693496
Other study ID # CAALC-002-mLOWER
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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