NCT02445183

Brief Summary

The COPDGene® / Lung Cancer Database Study is a nested case-control study. This study is an ancillary study to COPDGene® Phase 1 and Phase 2. Lung cancer cases, which have been reported by COPDGene® subjects since the time of COPDGene® study enrollment, will be retrospectively verified with additional medical data collection pertaining to lung cancer. Additional 'control' subjects will also be identified and verified as a 'no lung cancer controls'. Data previously collected through the COPDGene® Study, including QCT results and clinical results (medication use, rate of acute exacerbations of COPD, etc) will be used as variables for analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

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

December 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

6.8 years

First QC Date

May 11, 2015

Last Update Submit

March 2, 2021

Conditions

Lung CancerCOPD

Outcome Measures

Primary Outcomes (1)

  • Identify lung cancer variables

    Use existing COPDGene® quantitative HRCT and clinical data to perform a nested case-control study and perform a univariate analysis to select significant variables for the development of lung cancer.

    1.5 years

Secondary Outcomes (1)

  • Probability of lung cancer based on variables

    1.5 years

Study Arms (2)

Lung Cancer

Confirmed diagnosis of lung cancer

Other: None, N/A

No Lung Cancer Controls

Unconfirmed lung cancer diagnosis, false positive

Other: None, N/A

Interventions

None, N/AOTHER
Lung CancerNo Lung Cancer Controls

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects eligible for study are those enrolled in the COPDGene®. Subjects will be screened for enrollment through the COPDGene® longitudinal follow-up questionnaire or during their Phase 2 visit. Those patients that answer yes to "since the last follow up have you been diagnosed with cancer?" will be contacted by a study coordinator and offered enrollment in the COPDGene®/Lung Cancer Database.

You may qualify if:

  • Subjects must meet all of the following criteria
  • Be enrolled in COPDGene® Phase 1 with or without enrollment in Phase 2 with newly diagnosed, (within the time of enrollment), non-small cell lung cancer (NSCLC) or small-cell lung cancer (SCLC).
  • Documented GOLD stage 1-4 COPD or a history of smoking with no COPD
  • Signed HIPAA Research Authorization and a Release of Protected Health Information form to collect and review medical records regarding lung cancer diagnosis, treatment, and outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (2)

  • El Kaddouri B, Strand MJ, Baraghoshi D, Humphries SM, Charbonnier JP, van Rikxoort EM, Lynch DA. Fleischner Society Visual Emphysema CT Patterns Help Predict Progression of Emphysema in Current and Former Smokers: Results from the COPDGene Study. Radiology. 2021 Feb;298(2):441-449. doi: 10.1148/radiol.2020200563. Epub 2020 Dec 15.

    PMID: 33320065DERIVED

  • Bradford E, Jacobson S, Varasteh J, Comellas AP, Woodruff P, O'Neal W, DeMeo DL, Li X, Kim V, Cho M, Castaldi PJ, Hersh C, Silverman EK, Crapo JD, Kechris K, Bowler RP. The value of blood cytokines and chemokines in assessing COPD. Respir Res. 2017 Oct 24;18(1):180. doi: 10.1186/s12931-017-0662-2.

    PMID: 29065892DERIVED

MeSH Terms

Conditions

Lung NeoplasmsPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 15, 2015

Study Start

December 1, 2013

Primary Completion

September 22, 2020

Study Completion

September 22, 2020

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations

US(1)