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| ID | Type | Description | Link |
|---|---|---|---|
| JT 44147 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The COPD in LCS Registry will identify and characterize individuals who have functional or radiographic evidence of COPD and are receiving lung cancer screening. Clinical information will be obtained from study participants including symptom burden, lung cancer risk, spirometry, imaging characteristics, and peripheral blood eosinophils.
This study is a prospective cohort study and aims to characterize COPD and lung cancer screening outcomes among individuals receiving lung cancer screening, with the primary objective of determining feasibility of an LCS-facilitated process for identifying COPD cases.
The investigators anticipate enrolling 420 participants over 2 years. All study participants will undergo collection of clinical data at baseline and at 12-15 months. Study procedures at baseline include a blood draw for complete blood count (if not available within the prior 30 days), Pulmonary Function Testing (PFT) for spirometry and six-minute walk test (if not available within the prior 12 months). All participants will receive standard of care low-dose CT for lung cancer screening through Jefferson's LCS Program. Study participants will also complete surveys at baseline including:
Study participants will be followed for at least 15 months (to ascertain LCS annual adherence, defined as a repeat LDCT within 11-15 months of the prior LDCT). After enrollment completion, the Jefferson cohort will be combined with a cohort at the University of Michigan (MAP2 study, estimated n=200)
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| Measure | Description | Time Frame |
|---|---|---|
| COPD diagnosis based on meeting spirometric criteria | Will be based on meeting spirometric criteria for COPD (FEV^1/FVC =< 0.7) and have >1% low attenuation area on low-dose CT for LCS | 2 years |
| Accrual rate | Will be reported using percentages and 95% exact confidence intervals. | 2 years |
| Intervention compliance rate | Will be reported using percentages and 95% exact confidence intervals. | 2 years |
| Follow-up retention rate | Will be reported using percentages and 95% exact confidence intervals. | 2 years |
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Inclusion Criteria:
• * Eligible for lung cancer screening by USPSTF 2021 criteria including age 50-80 years and currently or formerly smoking with at last 20 pack-years of smoking history at the time of consent
Exclusion Criteria:
The presence of a respiratory condition other than COPD or asthma, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g. dyspnea or decreased exercise tolerance)Severe asthma, which is defined as any of the following:
Current (i.e. at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on LAMA; medium dose = >250 fluticasone propionate =100 fluticasone furoate, >200 beclomethasone, >400 budesonide, >220 mometasone). We will accept low-dose ICS/LABA or medium dose ICS or
3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months or
One asthma hospitalization in the past 12 months
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Patients eligible for lung cancer screening due to their age and history of tobacco use, and have COPD, chronic bronchitis, or emphysema
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Barta, MD, ATSF | Contact | 215-955-5161 | julie.barta@jefferson.edu | |
| Yolanda Kry, BS | Contact | 215-503-6234 | Yolanda.Kry@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Julie Barta, MD, ATSF | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Racial Differences in Lung Cancer Screening Beliefs and Screening Adherence. Clinical lung cancer. 2021;22(6):570-8. doi: | View source |
| Nonmalignant Surgical Resection Among Individuals with Screening-Detected Versus Incidental Lung Nodules. Clinical lung cancer. 2023. doi: | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Peripheral blood eosinophils will be obtained from study participants. Stored clinical and survey data will be stored electronically on the Redcap database for at least 5 years and may be used for future research. Future research outside the scope of this protocol will be reviewed by the IRB prior to proceeding. No genetic testing is performed in this study.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |