Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
- Conditions
- Lung CancerPrecancerous Condition
- Interventions
- Other: cytology and cytometry specimen collection procedureOther: Chest x rayProcedure: Autofluorescence bronchoscopyProcedure: CT scan
- Registration Number
- NCT00512746
- Lead Sponsor
- University College, London
- Brief Summary
RATIONALE: Screening tests or exams may help doctors find lung cancer sooner, when it may be easier to treat.
PURPOSE: This randomized clinical trial is studying screening tests or exams to see how well they work compared to usual care in finding early stage lung cancer in current or past smokers with chronic obstructive pulmonary disease.
- Detailed Description
OBJECTIVES:
Primary
* To show that the proportion of lung cancer diagnosed at stage I or II is significantly greater in the surveillance arm than in the control arm.
Secondary
* Establish whether sputum cytology and/or cytometry can be employed to stratify patients with chronic obstructive pulmonary disease (COPD) according to their risk of developing incidence lung cancer.
* Identify patients with pre-invasive lesions in their airways and examine the risk of developing lung cancer in patients harboring these lesions.
* Provide an opportunity to archive blood samples from patients under surveillance to enable the identification of markers of disease progression.
* Examine the compliance of regular screening among patients in this high-risk group.
* Determine the proportion of patients in which it is not possible to provide a sputum screening result.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to recruiting site, age, gender, smoking history (current vs ex-smoker) and severity of chronic obstructive pulmonary disease (COPD) (mild vs moderate). Patients are randomized to 1 of 2 arms.
* Control arm: Patients are managed according to the usual practice of their hospital or general practice for their COPD treatment. They undergo no particular investigations except those that may arise due to a change in their clinical condition. Those patients who are not diagnosed with lung cancer during the course of the study are offered a chest x-ray after 5 years of follow-up.
* Surveillance arm: Patients undergo surveillance for 5 years. A sputum sample is collected for cytology and cytometry. If the sputum sample is normal the patient is asked to provide a sputum sample annually. If the sputum sample is abnormal the patient undergoes an annual spiral CT scan followed by autofluorescence bronchoscopy. At bronchoscopy, the following samples are taken: bronchial washings, bronchial brushings, and bronchial biopsies. Bronchoscopy is repeated every 4-12 months depending upon the histology results. If an invasive lesion is found, the patient is referred for treatment via the normal hospital systems. Any remaining sputum sample is stored frozen as part of the tissue bank associated with this trial.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1569
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surveillance cytology and cytometry specimen collection procedure Screened arm Surveillance Chest x ray Screened arm Surveillance Autofluorescence bronchoscopy Screened arm Surveillance CT scan Screened arm Control Chest x ray Control arm
- Primary Outcome Measures
Name Time Method Proportion of lung cancer that is diagnosed as stage I or II 5 years In the control arm, it is expected that only 15% of cancers will be detected early. In the surveillance arm, we expect that at the time of the first screen, the detection rate of prevalence cancers will be about 3%, from data reported in CT screening studies
- Secondary Outcome Measures
Name Time Method Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend) 5 Years Proportion of patients in the surveillance arm who have abnormal sputum cytology 5 Years Proportion of patients in the surveillance arm who have abnormal sputum cytometry 5 Years Death from lung cancer Up to 15 years Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples) 5 Years Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry 5 Years Number of patients in the surveillance arm with pre-invasive lesions who develop lung cancer locally and at remote sites within the lung 5 Years
Trial Locations
- Locations (10)
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, England, United Kingdom
Chelsea Westminster Hospital
🇬🇧London, England, United Kingdom
University College Hospital - London
🇬🇧London, England, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, England, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, England, United Kingdom
Respiratory Research Office Belfast City Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, England, United Kingdom
Papworth Hospital
🇬🇧Cambridge, England, United Kingdom
Royal Brompton Hospital
🇬🇧London, England, United Kingdom