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

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Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsored by: Cancer Research UK

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00512746

Purpose
RATIONALE: Screening tests or exams may help doctors find lung cancer sooner, when it may be easier to treat.

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.



Condition Intervention
Lung Cancer
Precancerous/Nonmalignant Condition
Other: cytology specimen collection procedure
Other: sputum cytology
Procedure: annual screening
Procedure: bronchoscopic and lung imaging studies
Procedure: bronchoscopy
Procedure: computed tomography
Procedure: radiography




MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Cancer Lung Cancer
Drug Information available for: X-Rays
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening, Randomized, Active Control
Official Title: A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Proportion of lung cancer that is diagnosed as stage I or II [ Designated as safety issue: No ]



Secondary Outcome Measures:
Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend) [ Designated as safety issue: No ]

Proportion of patients in the surveillance arm who have abnormal sputum cytology [ Designated as safety issue: No ]

Proportion of patients in the surveillance arm who have abnormal sputum cytometry [ Designated as safety issue: No ]

Death from lung cancer [ Designated as safety issue: No ]

Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples) [ Designated as safety issue: No ]

Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry [ Designated as safety issue: No ]

Number of patients in the surveillance arm with pre-invasive lesions who develop lung cancer locally and at remote sites within the lung [ Designated as safety issue: No ]


Estimated Enrollment: 1300
Study Start Date: August 2007
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:

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. 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.

Eligibility


Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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: FEV_1/forced vital capacity (FVC) < 70%; FEV_1 &#8805; 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
Exclusion criteria:

Inadequate lung function (FEV_1 < 50% of predicted after bronchodilator)
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
PRIOR CONCURRENT THERAPY:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512746


Locations
United Kingdom, England
Chelsea Westminster Hospital Recruiting
London, England, United Kingdom, SW10 9NH
Contact: Pallav Shah, MD 44-20-8746-8000
Churchill Hospital Recruiting
Oxford, England, United Kingdom, OX3 7LJ
Contact: Mark Slade 44-186-574-1841
Leeds General Infirmary Recruiting
Leeds, England, United Kingdom, LS1 3EX
Contact: Contact Person 44-113-243-2799 paul.plant@leedsth.nhs.uk
Papworth Hospital Recruiting
Cambridge, England, United Kingdom, CB23 3RE
Contact: Robert Rintoul, MD 44-1480-364-342 robert.rintoul@papworth.nhs.uk
Walsgrave Hospital Recruiting
Coventry, England, United Kingdom, CV2 2DX
Contact: Paul Dhillon 44-247-696-4000
University College Hospital - London Recruiting
London, England, United Kingdom, WC1E 5DB
Contact: Jeremy George 44-207-380-9004
University College of London Hospitals Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Stephen G. Spiro 44-20-7679-8073
University Hospitals of Leicester NHS Trust Recruiting
Leicester, England, United Kingdom, LE3 9QP
Contact: Mick Peake 44-116-287-1471
Royal Brompton Hospital Recruiting
London, England, United Kingdom, SW3 6NP
Contact: Pallav Shah, MD 44-207-352-8121

Sponsors and Collaborators
Cancer Research UK
Investigators
Study Chair: Stephen G. Spiro University College London Hospitals

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000558413, CRUK-BRD/06/10, EU-20738, ISRCTN80745975
Study First Received: August 6, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00512746 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
small cell lung cancer
non-small cell lung cancer
precancerous/nonmalignant condition



Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Lung Diseases, Obstructive
Respiratory Tract Diseases
Precancerous Conditions
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Pulmonary Disease, Chronic Obstructive



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms



ClinicalTrials.gov processed this record on February 10, 2009


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