Expired Study
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Denver, Colorado 80206


Purpose:

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.


Study summary:

COPDGene® subjects will be screened through several mechanisms for enrollment into the Lung Cancer Database: 1. The COPDGene® Phase 1 Longitudinal Follow-up Questionnaire. 2. The COPDGene® Phase 2 Medical History Questionnaire at Visit 1 3. Medical Records Collection through the Mortality Adjudication Committee Potential cases will be those who respond yes to lung cancer will be contacted by phone by a study coordinator and be screened for the COPDGene® Lung Cancer Database. Medical records will be analyzed to determine the patient's cancer diagnosis, pathology, and treatment. Information will be collected at each individual institution, de-identified, and entered into the password-protected COPDGene® DCC lung cancer database, through a web-based interface. The survival data will be obtained through review of medical records or the Social Security Death Index in conjunction with the COPDGene® mortality adjudication committee. For the nested case-control study, controls will be matched from the those subjects on COPDGene who answered 'No' to the longitudinal follow-up question "have you been diagnosed with lung cancer" as per COPDGene protocol. Medical records regarding the patient's cancer diagnosis, pathology and treatment will be collected following signed release of medical information from the patient. The following information will be collected and entered into a database. The survival data will be obtained through review of medical records or the Social Security Death Index. i. Date of diagnosis ii. Type of specimen iii. Laterality iv. Lobe v. Record of any false positives (can be used as verified controls) b. Pathology Findings: i. Histology ii. Molecular Analysis, if done. iii. Stage (TNM classification) iv. Histologic grade c. Treatment i. Surgery ii. Radiation iii. Chemotherapy iv. Presentation at Tumor Board d. Outcomes i. Recurrence, Second primary cancers ii. Survival after cancer diagnosis, Cause of death Study coordinators at each site contact subjects who have self-reported lung cancer or were identified as having lung cancer by follow-up clinic visits and complete the lung cancer data form. The data collected on each subject is de-identified at the recruiting site prior to being downloaded into the COPDGene® DCC located at National Jewish Health. A lung cancer adjudication committee, including Drs. Carr and Bowler, will review each case for accuracy and completeness.


Criteria:

Inclusion Criteria: - Subjects must meet all of the following criteria 1. 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). 2. Documented GOLD stage 1-4 COPD or a history of smoking with no COPD 3. 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


Study is Available At:


Original ID:

HS 2815


NCT ID:

NCT02445183


Secondary ID:


Study Acronym:


Brief Title:

COPDGene/Lung Cancer Center Database


Official Title:

COPDGene/Lung Cancer Center Database


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

N/A


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Jewish Health


Oversight Authority:

United States: National Jewish Health Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational [Patient Registry]


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

250


Enrollment Type:

Anticipated


Study Dates

Start Date:December 2013
Completion Date:December 2019
Completion Type:Anticipated
Primary Completion Date:December 2019
Primary Completion Type:Anticipated
Verification Date:August 2019
Last Changed Date:August 20, 2019
First Received Date:May 11, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Probability of lung cancer based on variables
Time Frame:1.5 years
Safety Issues:False
Description:Construct a multivariate model from the results of the univariate analysis to calculate the odds ratios for the variables that predict lung cancer
Outcome Type:Primary Outcome
Measure:Identify lung cancer variables
Time Frame:1.5 years
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Other
Name:None, N/A
Arm Name:Lung Cancer

Study Arms

Study Arm Type:Other
Arm Name:No Lung Cancer Controls
Description:Unconfirmed lung cancer diagnosis, false positive
Study Arm Type:Other
Arm Name:Lung Cancer
Description:Confirmed diagnosis of lung cancer

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:National Jewish Health
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Boehringer Ingelheim

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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