A randomised controlled trial of surveillance for the early detection of lung cancer in an at risk group

ISRCTN	ISRCTN80745975
DOI	https://doi.org/10.1186/ISRCTN80745975
ClinicalTrials.gov number	NCT00512746
Secondary identifying numbers	BRD/06/107

Submission date: 01/02/2007
Registration date: 13/03/2007
Last edited: 23/09/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-to-find-out-if-screening-can-pick-up-lung-cancer-at-an-early-stage-in-a-high-risk-group-of-people-the-lungsearch-study

Contact information

Prof Stephen Spiro
Scientific

Department of Thoracic Medicine
University College London Hospitals NHS Trust
2nd Floor Maple House
Grafton Way
London
WC1E 5DB
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Screening
Scientific title	A randomised controlled trial of surveillance for the early detection of lung cancer in an at risk group
Study acronym	Lung-SEARCH
Study objectives	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(s)	South West Research Ethics Committee, 11/04/2007, ref: 07/MRE06/16
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2007
Completion date	01/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1700
Total final enrolment	1568
Key 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)
Key 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
Date of first enrolment	24/08/2007
Date of final enrolment	01/04/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London Hospitals NHS Trust

London
WC1E 5DB
United Kingdom

Sponsor information

University College London (UK)
University/education

University College London
Rowland Hill Street
London
NW3 2PF
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C5784/A7743)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2016		Yes	No
Abstract results	results presented at the European Respiratory Society Annual Congress	01/06/2012	15/04/2019	No	No
Results article	qualitative results from interviews of a sample of people accepting and declining participation	01/05/2012	15/04/2019	Yes	No
Plain English results			23/09/2020	No	Yes

Editorial Notes

23/09/2020: Cancer Research UK lay results summary link added to Results (plain English).
15/04/2019: The following changes have been made:
1. Publication references added.
2. The total final enrolment has been added.