Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT00512746|
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : December 21, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Precancerous Condition||Other: cytology and cytometry specimen collection procedure Other: Chest x ray Procedure: Autofluorescence bronchoscopy Procedure: CT scan||Not Applicable|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1569 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||March 2011|
Other: cytology and cytometry specimen collection procedure
Samples tested and further interventions added if positiveOther: Chest x ray
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years. This could help identify a lung cancer that may not have been associated with symptoms earlier.Procedure: Autofluorescence bronchoscopy
The bronchial tree will be inspected first under white light and then under blue light. All areas that appear abnormal will initially be documented and only sampled when the bronchoscopic examination has been completed.
Other Name: AFBProcedure: CT scan
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
Active Comparator: Control
Other: Chest x ray
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years. This could help identify a lung cancer that may not have been associated with symptoms earlier.
- Proportion of lung cancer that is diagnosed as stage I or II [ Time Frame: 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
- Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend) [ Time Frame: 5 Years ]
- Proportion of patients in the surveillance arm who have abnormal sputum cytology [ Time Frame: 5 Years ]
- Proportion of patients in the surveillance arm who have abnormal sputum cytometry [ Time Frame: 5 Years ]
- Death from lung cancer [ Time Frame: Up to 15 years ]
- Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples) [ Time Frame: 5 Years ]
- Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry [ Time Frame: 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 [ Time Frame: 5 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512746
|Cambridge, England, United Kingdom, CB23 3RE|
|Coventry, England, United Kingdom, CV2 2DX|
|Leeds General Infirmary|
|Leeds, England, United Kingdom, LS1 3EX|
|University Hospitals of Leicester NHS Trust|
|Leicester, England, United Kingdom, LE3 9QP|
|Chelsea Westminster Hospital|
|London, England, United Kingdom, SW10 9NH|
|Royal Brompton Hospital|
|London, England, United Kingdom, SW3 6NP|
|University College Hospital - London|
|London, England, United Kingdom, WC1E 5DB|
|Manchester, England, United Kingdom, M23 9LT|
|Sunderland Royal Hospital|
|Sunderland, England, United Kingdom, SR4 7TP|
|Respiratory Research Office Belfast City Hospital|
|Belfast, Northern Ireland, United Kingdom, BT9 7AB|
|Study Chair:||Stephen G. Spiro||University College London Hospitals|