NCT02693496

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

34 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

10 years

First QC Date

October 27, 2015

Last Update Submit

August 6, 2018

Conditions

Keywords

ResearchKitCT screeningEarly DiagnosisLung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Completed the installation and registration of mobile terminal software online

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Beijing Union Hospital

Beijing, China

RECRUITING

General Hospital of PLA

Beijing, China

RECRUITING

Hebei Pronvince Cangzhou City People's Hospital

Cangzhou, China

RECRUITING

Xiaya Hospital Central South Unversity

Changsha, China

RECRUITING

Anhui Province Chaoyang Hospital

Chaoyang, China

RECRUITING

West China Hospital Sichuan University

Chengdu, China

RECRUITING

No.1 Hospital Chongqing Medical University

Chongqing, China

RECRUITING

Western East Hospital No. 3 PLA Medical University

Chongqing, China

RECRUITING

No. 2 Hospital Dalian Medical University

Dalian, China

RECRUITING

Guizhou Province People's Hospital

Guizhou, China

RECRUITING

International Hospital Zhejiang University

Hangzhou, China

RECRUITING

No. 1 Hospital Zhejiang University Medical College

Hangzhou, China

RECRUITING

Yunnan Province Cancer Hospital

Kunming, China

RECRUITING

Shandong Province Liaocheng City People's Hospital

Liaocheng, China

RECRUITING

No. 2 Hospital Fujian Medical University

Quanzhou, China

RECRUITING

Kecheng District Hospital

Quzhou, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, 200032, China

RECRUITING

Minhang District Hospital Fudan University

Shanghai, China

RECRUITING

Putuo District Central Hospital Shanghai Chinese Medical University

Shanghai, China

RECRUITING

Ruici Clinic

Shanghai, China

RECRUITING

No. 2 Hospital Tianjin Chinese Medical University

Tianjin, China

RECRUITING

Weifang City No.2 People's Hospital

Weifang, China

RECRUITING

Wudang Hospital Guiyang Medical College

Wudang, China

RECRUITING

Wuhu City No. 2 Hopsital

Wuhu, China

RECRUITING

No. 5 Wuxi People's Hospital

Wuxi, China

RECRUITING

Xining Hospital No.4 PLA University

Xi'an, China

RECRUITING

Xiamen City No.3 People's Hospital

Xiamen, China

RECRUITING

Yantai City Taishan Hopsital

Yantai, China

RECRUITING

Henan Province People's Hospital

Zhengzhou, China

RECRUITING

No. 1 Hospital Zhengzhou University

Zhengzhou, China

RECRUITING

Shandong Pronvince Zibo City Official Hospital

Zibo, China

RECRUITING

Shandong Province Linzi District Hospital

Zibo, China

RECRUITING

Sichuan Province Zigong City No. 1 Hospital

Zigong, China

RECRUITING

Guizhou Province Zunyi Medical College Hospital

Zunyi, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26331818BACKGROUND
  • 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.

    PMID: 23649456BACKGROUND

MeSH Terms

Conditions

Solitary Pulmonary NoduleDiseaseLung Neoplasms

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Chunxue Bai, M.D, Ph.D

    Chinese Alliance Against Lung Cancer

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 27, 2015

First Posted

February 26, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations