NCT04049422

Brief Summary

The aim of this study is to identify the clinical features of pulmonary nodules and establish a cohort to identify biomarkers for lung cancer.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
40mo left

Started Aug 2019

Longer than P75 for all trials

Status
not yet recruiting

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 Progress68%
Aug 2019Jul 2029

First Submitted

Initial submission to the registry

August 5, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

August 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Expected
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

5 years

First QC Date

August 5, 2019

Last Update Submit

August 6, 2019

Conditions

Pulmonary Nodule, SolitaryLung Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of lung cancer

    incidence of pathologically proven lung cancer

    up to 5 years

Eligibility Criteria

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

People with pulmonary nodule(s) for which lung cancer is suspected

You may qualify if:

  • age \>= 18
  • pulmonary nodule(s) on chest CT, which satisfy at least one of the following two criteria,
  • A or above in Lung-RADS v1.1
  • lung cancer risk \>= 5% in Brock model

You may not qualify if:

  • already proven lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

bronchoalveolar lavage fluid, buffy coat, serum, plasma, urine

MeSH Terms

Conditions

Solitary Pulmonary NoduleLung Neoplasms

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Central Study Contacts

Young Sik Park, MD

CONTACT

+82-2-2072-7214mdyspark@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 8, 2019

Study Start

August 6, 2019

Primary Completion

July 31, 2024

Study Completion (Estimated)

July 31, 2029

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share