COPDGene/Lung Cancer Center Database
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02445183 |
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Recruitment Status :
Completed
First Posted : May 15, 2015
Last Update Posted : March 4, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Lung Cancer COPD | Other: None, N/A |
COPDGene® subjects will be screened through several mechanisms for enrollment into the Lung Cancer Database:
- The COPDGene® Phase 1 Longitudinal Follow-up Questionnaire.
- The COPDGene® Phase 2 Medical History Questionnaire at Visit 1
- 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.
| Study Type : | Observational [Patient Registry] |
| Actual 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 |
| Actual Primary Completion Date : | September 22, 2020 |
| Actual Study Completion Date : | September 22, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Lung Cancer
Confirmed diagnosis of lung cancer
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Other: None, N/A |
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No Lung Cancer Controls
Unconfirmed lung cancer diagnosis, false positive
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Other: None, N/A |
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
Inclusion Criteria:
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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
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
| United States, Colorado | |
| National Jewish Health | |
| Denver, Colorado, United States, 80206 | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Jewish Health |
| ClinicalTrials.gov Identifier: | NCT02445183 |
| Other Study ID Numbers: |
HS 2815 |
| First Posted: | May 15, 2015 Key Record Dates |
| Last Update Posted: | March 4, 2021 |
| Last Verified: | March 2021 |
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Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |