Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Intervention compliance rate
研究概览
简要总结
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.
详细描述
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:
- Respiratory Medication Use Questionnaire
- Respiratory Disease and Smoke Exposure Questionnaire
- CAPTURE Questionnaire
- COPD Assessment Test
- CAPTURE Questionnaire Potential participants will be recruited through the Jefferson LCS Program. The LCS Program clinical nurse navigator and research nurse navigator will assess eligibility at the time of referral to the LCS Program. Participants who have already had a PFT within 12 months will be consented and enrolled at their standard of care LCS Program appointment. The blood draw (if needed) and study questionnaires will be done immediately following the LCS Program appointment. Participants who need a first-time or updated PFT will be scheduled for a separate visit with the research nurse to provide consent, enroll on the study, and perform all study procedures.
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• * 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
- •Willingness to participate in an observational clinical trial and to be contacted about future ancillary studies that could include interventional clinical trials
- •Ability to tolerate study procedures
- •Ability to provide informed consent
- •Clinical Lung Cancer Screening CT performed at the University of Michigan within the last year
- •Meets one of the three following criteria: 1) Prior Diagnosis of COPD in the EMR 2) Prior pulmonary function meeting criteria for COPD (FEV1/FVC ≤ 0.70) or 3) LAA>1% on lung cancer screening CT scan
排除标准
- •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
- •Concurrent participation in a therapeutic trial where treatment is blinded
- •Active pregnancy. Documentation of birth control will be required for pre-menopausal women
- •Cognitive dysfunction that prevents the participant from completing study procedures
- •BMI > 35 kg/m2 at baseline, due to the effects of body weight on CT scan quality
- •Current illicit substance abuse, including cannabis smoking
- •Any illness expected to cause mortality in the next 3 years
- •Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan quality
- •History of thoracic radiation or thoracic surgery with resection of lung tissue
- •Participants who present with an acute exacerbation of COPD, either solely participant-identified or that has been clinically treated, in the last 30 days can be rescreened for the study once the 30-day window from end of drug therapy has passed
- •Participants who present with current use of acute antibiotics or steroids can be rescreened for the study >= 30 days after discontinuing acute antibiotics/steroids. This restriction does not apply to participants who are on chronic prednisone therapy of <10 mg per day or <20 mg every other day or participants who are currently on chronic, prophylactic, or suppressive antibiotic therapy
结局指标
主要结局
Intervention compliance rate
时间窗: 2 years
Will be reported using percentages and 95% exact confidence intervals.
Follow-up retention rate
时间窗: 2 years
Will be reported using percentages and 95% exact confidence intervals.
COPD diagnosis based on meeting spirometric criteria
时间窗: 2 years
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
Accrual rate
时间窗: 2 years
Will be reported using percentages and 95% exact confidence intervals.
次要结局
未报告次要终点