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

Phase 3

Completed

• Conditions: ung cancer; Cancer; Malignant neoplasm of the lung

• Registration Number: ISRCTN80745975
• Lead Sponsor: niversity College London (UK)

Brief Summary

1. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26138736 2. 2012 qualitative results from interviews of a sample of people accepting and declining participation in: https://www.ncbi.nlm.nih.gov/pubmed/22106018 (added 15/04/2019) 3. 2012 results presented at the European Respiratory Society Annual Congress 2012 in: https://erj.ersjournals.com/content/40/Suppl_56/1638 (added 15/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-13
• Study Completion: 2014-05-01
• Last Update Posted: 5 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1568

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the proportion of lung cancers that are diagnosed at stage I or II.

Secondary Outcome Measures

Name	Time	Method
<br> 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.<br> 2. The proportion of patients in the surveillance arm who have abnormal sputum cytology<br> 3. The proportion of patients in the surveillance arm who have abnormal sputum cytometry<br> 4. Death from lung cancer<br> 5. Proportion of failed sputum samples, i.e. where it is not possible to obtain adequate sputum samples<br> 6. Prevalence of pre-invasive disease in patients with abnormal cytometry in the<br> active arm<br> 7. Numbers of patients with pre-invasive lesions developing lung cancer locally and at remote sites within the lung in the active arm<br>