Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
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.
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.
DISEASE CHARACTERISTICS:

 Inclusion criteria:

 -  Meets 1 of the following criteria:

 -  Current smoker, defined as ≥ a 20 pack year smoking history and/or 20 year
 duration of smoking

 -  Ex-smoker who has quit smoking within the past 8 years AND has ≥ a 20 pack year
 smoking history and/or 20 year duration of smoking

 -  Mild to moderate chronic obstructive pulmonary disease (COPD) as defined by the GOLD
 criteria

 -  Mild COPD: FEV_1/forced vital capacity (FVC) < 70%; FEV_1 ≥ 80% of predicted*

 -  Moderate COPD: FEV_1/FVC < 70%; FEV_1 50-80% of predicted* NOTE: *Spirometric
 values will be obtained post bronchodilator according to the recommendations in
 the GOLD criteria

 Exclusion criteria:

 -  Inadequate lung function (FEV_1 < 50% of predicted after bronchodilator)

 PATIENT CHARACTERISTICS:

 Inclusion criteria:

 -  Life expectancy must be at least 5 years

 Exclusion criteria:

 -  History of malignant disease within the past 5 years except non-melanomatous skin
 cancers

 -  Other serious co-morbidity

 -  Evidence of severe or uncontrolled systemic diseases that, in the view of the
 investigator, makes it undesirable for the patient to participate in this trial

 -  Any disorder making reliable informed consent impossible

 -  Unlikely to co-operate with a 5 year follow-up

 PRIOR CONCURRENT THERAPY:

 -  Patients may receive all concurrent therapy deemed to provide adequate care as decided
 by their medical doctors