Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00512746
Protocol/serial number
BRD/06/107
Study information
Scientific title
A randomised controlled trial of surveillance for the early detection of lung cancer in an at risk group
Acronym
Lung-SEARCH
Study hypothesis
The trial will test the hypothesis that annual surveillance of chronic obstructive pulmonary disease (COPD) patients who are long-term smokers with abnormal sputum cytology and/or cytometry using fluorescence bronchoscopy and low dose spiral computed tomography (CT) detects a large proportion of lung cancer incidence at early stages when curative treatment is feasible.
Please note that as of 03/10/2008 this record has been updated. Any changes to the trial information can be found in the relevant field under the above update date.
On 17/02/2011 the target number of participants was changed from 1300 to 1700.
Ethics approval
South West Research Ethics Committee, 11/04/2007, ref: 07/MRE06/16
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Condition
Lung cancer
Intervention
Amended as of 03/10/2008:
Point one in the surveillance arm (a baseline blood sample will be taken) has now been removed from the interventions section. All other information remains the same.
Initial information at time of registration:
In the surveillance arm:
1. A baseline blood sample will be taken
2. A sputum sample will be collected for cytology and cytometry:
2.1. Normal sputum = sputum without metaplastic cells, only containing alveolar macrophages. If the sputum sample is normal the subject will be asked to provide sputum annually.
2.2. Abnormal sputum = low-grade (LSIL) and high-grade lesion (HSIL) squamous intraepithelial lesions. If the sputum sample is abnormal the subject will have an annual CT scan followed by a fluorescence bronchoscopy. The frequency of bronchoscopy is dependent upon the histology results.
In the control arm:
Patients recruited into the control arm will be managed according to the usual practice of their hospital or general practice for their COPD treatment. They will have no particular investigations except those that may arise due to a change in their clinical condition. However, those patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
The primary endpoint is the proportion of lung cancers that are diagnosed at stage I or II.
Secondary outcome measures
1. Uptake of screening (the proportion of patients in the surveillance arm who attend each year, among those invited to attend). This can be further divided into those who decline auto-FB, CT scan or yearly sputum.
2. The proportion of patients in the surveillance arm who have abnormal sputum cytology
3. The proportion of patients in the surveillance arm who have abnormal sputum cytometry
4. Death from lung cancer
5. Proportion of failed sputum samples, i.e. where it is not possible to obtain adequate sputum samples
6. Prevalence of pre-invasive disease in patients with abnormal cytometry in the
active arm
7. Numbers of patients with pre-invasive lesions developing lung cancer locally and at remote sites within the lung in the active arm
Overall trial start date
01/05/2007
Overall trial end date
01/05/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Amended as of 03/10/2008:
Point two of the inclusion criteria has been amended as follows:
2. Ex-smokers who have quit within 8 years with a greater than or equal to 20 pack-years smoking history and/or 20-year duration of smoking
Initial information at time of registration:
1. Current smokers: greater than or equal to 20 pack-years smoking history and/or 20-year duration of smoking
2. Ex-smokers who have quit within 5 years with a greater than or equal to 20 pack-years smoking history and/or 20-year duration of smoking
3. No upper age limit but life expectancy must be at least 5 years
4. No history of malignant disease during the previous 5 years except non-melanomatous skin cancers
5. No other serious co-morbidity
6. Written informed consent
7. Mild to moderate COPD as defined by the Global Initiative on Obstructive Lung Disease (GOLD) criteria
8. Mild:
8.1. Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 70
8.2. FEV1 greater than or equal to 80% predicted
9. Moderate:
9.1. FEV1/FVC less than 70%
9.2. FEV1 50-80% predicted
(Spirometric values will be taken post bronchodilator according to the recommendations in the GOLD criteria)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1700
Participant exclusion criteria
1. Inadequate lung function (FEV1 less than 50% predicted after bronchodilator)
2. History of malignant disease during the previous 5 years except non melanomatous skin cancers
3. Evidence of severe or uncontrolled systemic diseases that, in the view of the investigator, makes it undesirable for the patient to participate in the trial
4. Any disorder making reliable informed consent impossible
5. Patient unlikely to co-operate with a 5 year follow up
Recruitment start date
24/08/2007
Recruitment end date
01/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London Hospitals NHS Trust
London
WC1E 5DB
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C5784/A7743)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 research in progress article: http://www.ncbi.nlm.nih.gov/pubmed/26138736