Mobile Lung Nodule Observatory for Worldwide, Evidenced-based Research

NCT ID: NCT02693496

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2025-10-31

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.

Conditions

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Solitary Pulmonary Nodule

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Installation or registration of smartphone application

Completed the installation and registration of mobile terminal software online

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Alliance Against Lung Cancer

OTHER

Sponsor Role lead

Responsible Party

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Bai Chunxue

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunxue Bai, M.D, Ph.D

Role: STUDY_CHAIR

Chinese Alliance Against Lung Cancer

Locations

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Beijing Union Hospital

Beijing, , China

Site Status RECRUITING

General Hospital of PLA

Beijing, , China

Site Status RECRUITING

Hebei Pronvince Cangzhou City People's Hospital

Cangzhou, , China

Site Status RECRUITING

Xiaya Hospital Central South Unversity

Changsha, , China

Site Status RECRUITING

Anhui Province Chaoyang Hospital

Chaoyang, , China

Site Status RECRUITING

West China Hospital Sichuan University

Chengdu, , China

Site Status RECRUITING

No.1 Hospital Chongqing Medical University

Chongqing, , China

Site Status RECRUITING

Western East Hospital No. 3 PLA Medical University

Chongqing, , China

Site Status RECRUITING

No. 2 Hospital Dalian Medical University

Dalian, , China

Site Status RECRUITING

Guizhou Province People's Hospital

Guizhou, , China

Site Status RECRUITING

International Hospital Zhejiang University

Hangzhou, , China

Site Status RECRUITING

No. 1 Hospital Zhejiang University Medical College

Hangzhou, , China

Site Status RECRUITING

Yunnan Province Cancer Hospital

Kunming, , China

Site Status RECRUITING

Shandong Province Liaocheng City People's Hospital

Liaocheng, , China

Site Status RECRUITING

No. 2 Hospital Fujian Medical University

Quanzhou, , China

Site Status RECRUITING

Kecheng District Hospital

Quzhou, , China

Site Status RECRUITING

Shanghai Zhongshan Hospital

Shanghai, , China

Site Status RECRUITING

Minhang District Hospital Fudan University

Shanghai, , China

Site Status RECRUITING

Putuo District Central Hospital Shanghai Chinese Medical University

Shanghai, , China

Site Status RECRUITING

Ruici Clinic

Shanghai, , China

Site Status RECRUITING

No. 2 Hospital Tianjin Chinese Medical University

Tianjin, , China

Site Status RECRUITING

Weifang City No.2 People's Hospital

Weifang, , China

Site Status RECRUITING

Wudang Hospital Guiyang Medical College

Wudang, , China

Site Status RECRUITING

Wuhu City No. 2 Hopsital

Wuhu, , China

Site Status RECRUITING

No. 5 Wuxi People's Hospital

Wuxi, , China

Site Status RECRUITING

Xining Hospital No.4 PLA University

Xi'an, , China

Site Status RECRUITING

Xiamen City No.3 People's Hospital

Xiamen, , China

Site Status RECRUITING

Yantai City Taishan Hopsital

Yantai, , China

Site Status RECRUITING

Henan Province People's Hospital

Zhengzhou, , China

Site Status RECRUITING

No. 1 Hospital Zhengzhou University

Zhengzhou, , China

Site Status RECRUITING

Shandong Pronvince Zibo City Official Hospital

Zibo, , China

Site Status RECRUITING

Shandong Province Linzi District Hospital

Zibo, , China

Site Status RECRUITING

Sichuan Province Zigong City No. 1 Hospital

Zigong, , China

Site Status RECRUITING

Guizhou Province Zunyi Medical College Hospital

Zunyi, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunxue Bai, M.D, Ph.D

Role: CONTACT

+86 186-2117-0011

Facility Contacts

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Li Zhang

Role: primary

Liangan Chen

Role: primary

Rongjiang Xie

Role: primary

Chengping Hu

Role: primary

Xiaohong Li

Role: primary

Weimin Li

Role: primary

Shuliang Guo

Role: primary

Xiangdong Zhou

Role: primary

Qi Wang

Role: primary

Xianwei Ye

Role: primary

Jie Zheng

Role: primary

Jianying Zhou

Role: primary

Yunchao Wang

Role: primary

Peige Zhao

Role: primary

Yiming Zeng

Role: primary

Weiping Liu

Role: primary

Dawei Yang, M.D.

Role: primary

+86 13564703813

Xiwen Gao

Role: primary

Xiongbiao Wang

Role: primary

Xiaoli Wang

Role: primary

Hong Zhang

Role: primary

Guoru Yang

Role: primary

Chunyan Wang

Role: primary

Gang Yang

Role: primary

Xinguo Zhao

Role: primary

Jian Zhang

Role: primary

Ye Lu

Role: primary

Enning Zhang

Role: primary

Xiaoju Zhang

Role: primary

Jing Wang

Role: primary

Rongxu Li

Role: primary

Lixin Fang

Role: primary

Zhi Deng

Role: primary

Jianyong Zhang

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 26331818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23649456 (View on PubMed)

Other Identifiers

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CAALC-002-mLOWER

Identifier Type: -

Identifier Source: org_study_id

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