NCT04036903

Brief Summary

Lung cancer is one of main cause of cancer death in worldwide, characterized of low 5-year survival rate of less than 20%. Pulmonary nodule is considered as the typical imaging manifestation in early stage of lung cancer. The National Lung Screen Trial has demonstrated that the mortality rates could decline greatly, by the utility of low-dose helical computed tomography for screen of pulmonary nodules. Thus, automatic detection, diagnosis and management of pulmonary nodules, play the vital roles in computer-aided lung cancer screening and early intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

July 26, 2019

Last Update Submit

February 7, 2023

Conditions

Lung Cancer

Keywords

Lung nodulesDeep learning

Outcome Measures

Primary Outcomes (4)

  • accuracy

    proportion of true results(both true positives and true negatives) among whole instances

    2 years

  • sensitivity

    true positive rate in percentage(%) derived by ROC analysis

    2 years

  • specificity

    true negative rate in percentage (%) derived by ROC analysis

    2 years

  • area under curve (AUC)

    area under ROC curve in percentage (%)

    2 years

Secondary Outcomes (2)

  • average number of false positives per scan (FPs/scan)

    2 years

  • competition performance metric (CPM)

    2 years

Interventions

computed tomographyRADIATION

thoracic CT examinations for diagnosis, and/or follow-up.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This is a single institutional retrospective cohort study of patients within hospitals in Hong Kong, who had undergone thoracic CT for suspicious lung nodules.

You may qualify if:

  • Subjects with suspicious lung nodules.
  • Thin-layer thoracic CT and pathology examination have been performed for suspicious lung nodules.

You may not qualify if:

  • Subjects with accompanied lesions on CT images that may interfere to lung nodules analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wale Hospital

Hong Kong, Shatin, Hong Kong

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 30, 2019

Study Start

July 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)