- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04036903
D-Lung: An Analytics Platform for Lung Cancer Based on Deep Learning Technology
February 7, 2023 updated by: Professor Winnie W.C. Chu, Chinese University of Hong Kong
D-Lung: An Analytics Platform for Primary Lung Cancer Screening, Diagnosis and Management Based on Deep Learning Technology
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shatin
-
Hong Kong, Shatin, Hong Kong
- The Chinese University of Hong Kong, Prince of Wale Hospital
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- Subjects with suspicious lung nodules.
- Thin-layer thoracic CT and pathology examination have been performed for suspicious lung nodules.
Exclusion Criteria:
- Subjects with accompanied lesions on CT images that may interfere to lung nodules analysis
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
accuracy
Time Frame: 2 years
|
proportion of true results(both true positives and true negatives) among whole instances
|
2 years
|
|
sensitivity
Time Frame: 2 years
|
true positive rate in percentage(%) derived by ROC analysis
|
2 years
|
|
specificity
Time Frame: 2 years
|
true negative rate in percentage (%) derived by ROC analysis
|
2 years
|
|
area under curve (AUC)
Time Frame: 2 years
|
area under ROC curve in percentage (%)
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
average number of false positives per scan (FPs/scan)
Time Frame: 2 years
|
FPs/scan in number (N) based on free-response receiver operating characteristic (FROC) analysis
|
2 years
|
|
competition performance metric (CPM)
Time Frame: 2 years
|
Competitive performance metric (CPM) is a criterion used for CAD system evaluation.
Based on FROC paradigm, CPM score is computed as an average sensitivity at seven predefined average false positive rates.
CPM score ranges from 0 to 1, with higher CPM score indicating better CAD performance.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (ACTUAL)
July 1, 2018
Primary Completion (ACTUAL)
June 30, 2020
Study Completion (ACTUAL)
June 30, 2020
Study Registration Dates
First Submitted
July 26, 2019
First Submitted That Met QC Criteria
July 26, 2019
First Posted (ACTUAL)
July 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.