Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Screening Active Not specified Other CRUK-BRD/06/10 EU-20738, ISRCTN80745975, NCT00512746

Objectives

Primary

1. 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

1. 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.
2. Identify patients with pre-invasive lesions in their airways and examine the risk of developing lung cancer in patients harboring these lesions.
3. Provide an opportunity to archive blood samples from patients under surveillance to enable the identification of markers of disease progression.
4. Examine the compliance of regular screening among patients in this high-risk group.
5. Determine the proportion of patients in which it is not possible to provide a sputum screening result.

Entry Criteria

Disease Characteristics:

Inclusion criteria:

• Meets 1 of the following 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 5 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: FEV₁/forced vital capacity (FVC) < 70%; FEV₁ ≥ 80% of predicted*
  • Moderate COPD: FEV₁/FVC < 70%; FEV₁ 50-80% of predicted*

   [Note: *Spirometric values will be obtained post bronchodilator according to the recommendations in the GOLD criteria]

Exclusion criteria:

• Inadequate lung function (FEV₁ < 50% of predicted after bronchodilator)

Prior/Concurrent Therapy:

• Patients may receive all concurrent therapy deemed to provide adequate care as decided by their medical doctors

Patient Characteristics:

Inclusion criteria:

• Life expectancy must be at least 5 years

Exclusion criteria:

• 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

Expected Enrollment

Outcomes

Proportion of lung cancer that is diagnosed as stage I or II

Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)
Proportion of patients in the surveillance arm who have abnormal sputum cytology
Proportion of patients in the surveillance arm who have abnormal sputum cytometry
Death from lung cancer
Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples)
Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry
Number of patients in the surveillance arm with pre-invasive lesions who develop lung cancer locally and at remote sites within the lung

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. Blood samples are taken annually. 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.

Trial Contact Information

Trial Lead Organizations

Cancer Research UK and University College London Cancer Trials Centre

Stephen G. Spiro, Protocol chair		Ph: 44-20-7679-8073

United Kingdom
England
	Cambridge
	Papworth Hospital
		Robert Rintoul, MD	Ph:  44-1480-364-342
			Email: robert.rintoul@papworth.nhs.uk
	Coventry
	Walsgrave Hospital
		Paul Dhillon	Ph:  44-247-696-4000
	Leeds
	Leeds General Infirmary
		Contact Person	Ph:  44-113-243-2799
			Email: paul.plant@leedsth.nhs.uk
	Leicester
	University Hospitals of Leicester NHS Trust
		Mick Peake	Ph:  44-116-287-1471
	London
	Chelsea Westminster Hospital
		Pallav Shah, MD	Ph:  44-20-8746-8000
	Royal Brompton Hospital
		Pallav Shah, MD	Ph:  44-207-352-8121
	University College Hospital - London
		Jeremy George	Ph:  44-207-380-9004
	University College of London Hospitals
		Stephen G. Spiro	Ph:  44-20-7679-8073
	Oxford
	Churchill Hospital
		Mark Slade	Ph:  44-186-574-1841

Registry Information
Official Title		A randomised controlled trial of surveillance for the early detection of lung Cancer in an at risk group [Lung-SEARCH trial]
Trial Start Date		2007-08-24
Trial Completion Date		2009-08-23 (estimated)
Registered in ClinicalTrials.gov		NCT00512746
Date Submitted to PDQ		2007-06-26
Information Last Verified		2008-12-16