Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
NCT ID: NCT00512746
Last Updated: 2011-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1569 participants
INTERVENTIONAL
2007-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Surveillance
Screened arm
cytology and cytometry specimen collection procedure
Samples tested and further interventions added if positive
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.
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.
CT scan
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
Control
Control arm
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cytology and cytometry specimen collection procedure
Samples tested and further interventions added if positive
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.
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.
CT scan
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* Life expectancy must be at least 5 years
Exclusion Criteria
PATIENT CHARACTERISTICS:
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephen G. Spiro
Role: STUDY_CHAIR
University College London Hospitals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Papworth Hospital
Cambridge, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Leeds General Infirmary
Leeds, England, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, England, United Kingdom
Chelsea Westminster Hospital
London, England, United Kingdom
Royal Brompton 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Spiro SG, Hackshaw A; LungSEARCH Collaborative Group. Research in progress--LungSEARCH: a randomised controlled trial of surveillance for the early detection of lung cancer in a high-risk group. Thorax. 2016 Jan;71(1):91-3. doi: 10.1136/thoraxjnl-2015-207433. Epub 2015 Jul 2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRUK-BRD/06/10
Identifier Type: -
Identifier Source: secondary_id
EU-20738
Identifier Type: -
Identifier Source: secondary_id
ISRCTN80745975
Identifier Type: -
Identifier Source: secondary_id
CDR0000558413
Identifier Type: -
Identifier Source: org_study_id