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Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators anticipate enrolling 420 participants over 2 years."
  • "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 blood draw (if needed) and study questionnaires will be done immediately following the LCS Program appointment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects health information from people getting lung cancer screening who have signs of COPD, a long-term lung disease that makes breathing harder. It looks at symptoms, lung cancer risk, breathing tests, lung scans, and blood tests. It is an observational study, not a treatment trial.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Meet the 2021 U.S. lung cancer screening rules, including being age 50–80 and a current or former smoker with at least 20 pack-years of smoking. One pack-year means smoking one pack a day for one year.
  • Be willing to join an observational study and be contacted about future studies, which may test treatments.
  • Be able to handle the study procedures.
  • Be able to understand the study and give consent to join.
  • Have had a lung cancer screening CT scan at the University of Michigan within the past year.
  • Have at least one sign of COPD: a diagnosis in your medical record, a past breathing test meeting the study’s COPD cutoff, or certain lung changes affecting more than 1% of your screening CT scan.

Who can't join

  • Have a lung condition other than COPD or asthma, or another health condition that the study doctor thinks is the main cause of your breathing problems.
  • Have severe asthma: use higher-level asthma treatment as defined by the study, have had at least 3 unplanned asthma care visits in the past year, or have been hospitalized for asthma in the past year.
  • Be in another treatment study where the treatment assignment is kept hidden, or be pregnant. Women who have not gone through menopause must provide birth control records.
  • Have thinking or memory problems that prevent study tasks, or an illness expected to cause death within 3 years.
  • Have a body mass index (BMI, a measure of weight compared with height) over 35, or metal implants above the waist that could make chest CT images less clear.
  • Currently misuse illegal drugs, including smoking cannabis.
  • Have had radiation treatment to the chest or chest surgery that removed lung tissue.
  • Have had a COPD flare-up in the past 30 days, or currently use short-term antibiotics or steroids. You may be checked again at least 30 days after treatment ends. This rule does not apply to ongoing antibiotics or ongoing prednisone below 10 mg daily or below 20 mg every other day.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 * 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 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 * 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

Study sites (1)

PA