- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04049422
Pulmonary Nodule Cohort (liquidNodule)
August 6, 2019 updated by: Young Sik Park, Seoul National University Hospital
The aim of this study is to identify the clinical features of pulmonary nodules and establish a cohort to identify biomarkers for lung cancer.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
1000
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
- Name: Young Sik Park, MD
- Phone Number: +82-2-2072-7214
- Email: mdyspark@gmail.com
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
People with pulmonary nodule(s) for which lung cancer is suspected
Description
Inclusion Criteria:
- age >= 18
pulmonary nodule(s) on chest CT, which satisfy at least one of the following two criteria,
- 4A or above in Lung-RADS v1.1
- lung cancer risk >= 5% in Brock model
Exclusion Criteria:
- already proven lung cancer
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 |
|---|---|---|
|
Incidence of lung cancer
Time Frame: up to 5 years
|
incidence of pathologically proven lung cancer
|
up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
August 6, 2019
Primary Completion (Anticipated)
July 31, 2024
Study Completion (Anticipated)
July 31, 2029
Study Registration Dates
First Submitted
August 5, 2019
First Submitted That Met QC Criteria
August 6, 2019
First Posted (Actual)
August 8, 2019
Study Record Updates
Last Update Posted (Actual)
August 8, 2019
Last Update Submitted That Met QC Criteria
August 6, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1907-099-1048
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.