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

August 6, 2018 updated by: Bai Chunxue, Chinese Alliance Against Lung Cancer

Mobile Lung Nodule Observatory for Worldwide, Evidenced - Based Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
      • Beijing, China
      • Cangzhou, China
        • Recruiting
        • Hebei Pronvince Cangzhou City People's Hospital
        • Contact:
      • Changsha, China
        • Recruiting
        • Xiaya Hospital Central South Unversity
        • Contact:
      • Chaoyang, China
        • Recruiting
        • Anhui Province Chaoyang Hospital
        • Contact:
      • Chengdu, China
        • Recruiting
        • West China Hospital Sichuan University
        • Contact:
      • Chongqing, China
        • Recruiting
        • No.1 Hospital Chongqing Medical University
        • Contact:
      • Chongqing, China
        • Recruiting
        • Western East Hospital No. 3 PLA Medical University
        • Contact:
      • Dalian, China
        • Recruiting
        • No. 2 Hospital Dalian Medical University
        • Contact:
      • Guizhou, China
        • Recruiting
        • GuiZhou Province People's Hospital
        • Contact:
      • Hangzhou, China
        • Recruiting
        • International Hospital Zhejiang University
        • Contact:
      • Hangzhou, China
        • Recruiting
        • No. 1 Hospital Zhejiang University Medical College
        • Contact:
      • Kunming, China
      • Liaocheng, China
        • Recruiting
        • Shandong Province Liaocheng City People's Hospital
        • Contact:
      • Quanzhou, China
        • Recruiting
        • No. 2 Hospital Fujian Medical University
        • Contact:
      • Quzhou, China
        • Recruiting
        • Kecheng District Hospital
        • Contact:
      • Shanghai, China, 200032
        • Recruiting
        • Shanghai Zhongshan Hospital
        • Contact:
        • Principal Investigator:
          • Chunxue Bai, Prof.
        • Sub-Investigator:
          • Dawei Yang, M.D.
      • Shanghai, China
        • Recruiting
        • Minhang District Hospital Fudan University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Putuo District Central Hospital Shanghai Chinese Medical University
        • Contact:
      • Shanghai, China
      • Tianjin, China
        • Recruiting
        • No. 2 Hospital Tianjin Chinese Medical University
        • Contact:
      • Weifang, China
        • Recruiting
        • Weifang City No.2 People's Hospital
        • Contact:
      • Wudang, China
      • Wuhu, China
      • Wuxi, China
        • Recruiting
        • No. 5 Wuxi People's Hospital
        • Contact:
      • Xiamen, China
        • Recruiting
        • Xiamen City No.3 People's Hospital
        • Contact:
      • Xian, China
        • Recruiting
        • Xining Hospital No.4 PLA University
        • Contact:
      • Yantai, China
      • Zhengzhou, China
      • Zhengzhou, China
      • Zibo, China
        • Recruiting
        • Shandong Pronvince Zibo City Official Hospital
        • Contact:
      • Zibo, China
        • Recruiting
        • Shandong Province Linzi District Hospital
        • Contact:
      • Zigong, China
        • Recruiting
        • Sichuan Province Zigong City No. 1 Hospital
        • Contact:
      • Zunyi, China
        • Recruiting
        • Guizhou Province Zunyi Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 10,000 patients will participate in this research program, in 100 different medical institutions.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the diagnostic accuracy among different type of lung nodules.
Time Frame: 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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Alliance Against Lung Cancer

Investigators

  • Study Chair: Chunxue Bai, M.D, Ph.D, Chinese Alliance Against Lung Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAALC-002-mLOWER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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