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COPDGene/Lung Cancer Center Database

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ClinicalTrials.gov Identifier: NCT02445183
Recruitment Status : Enrolling by invitation
First Posted : May 15, 2015
Last Update Posted : April 3, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
National Jewish Health

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.

Condition or disease Intervention/treatment
Lung Cancer COPD Other: None, N/A

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: COPDGene/Lung Cancer Center Database
Study Start Date : December 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Identify lung cancer variables [ Time Frame: 1.5 years ]
    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.


Secondary Outcome Measures :
  1. Probability of lung cancer based on variables [ Time Frame: 1.5 years ]
    Construct a multivariate model from the results of the univariate analysis to calculate the odds ratios for the variables that predict lung cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445183


Locations
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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Boehringer Ingelheim

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT02445183     History of Changes
Other Study ID Numbers: HS 2815
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases