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Randomized Study of Surveillance For the Early Detection of Lung Cancer in Current or Former Smokers With Mild to Moderate Chronic Obstructive Pulmonary Disease
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
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Protocol IDs
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No phase specified
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Screening
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Active
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Not specified
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Other
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CRUK-BRD/06/10 EU-20738, ISRCTN80745975, NCT00512746
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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.
Entry Criteria Disease Characteristics:
Inclusion 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 1300Outcomes Primary Outcome(s)Proportion of lung cancer that is diagnosed as stage I or II
Secondary Outcome(s)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 | | | | Trial Sites
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United Kingdom |
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England |
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Cambridge |
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| | | | Papworth Hospital |
| | Robert Rintoul, MD | |
| Email:
robert.rintoul@papworth.nhs.uk |
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Coventry |
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| | Walsgrave Hospital |
| | Paul Dhillon | |
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Leeds |
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| | Leeds General Infirmary |
| | Contact Person | |
| Email:
paul.plant@leedsth.nhs.uk |
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Leicester |
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| | University Hospitals of Leicester NHS Trust |
| | Mick Peake | |
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London |
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| | Chelsea Westminster Hospital |
| | Pallav Shah, MD | |
| | Royal Brompton Hospital |
| | Pallav Shah, MD | |
| | University College Hospital - London |
| | Jeremy George | |
| | University College of London Hospitals |
| | Stephen G. Spiro | |
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Oxford |
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| | Churchill Hospital |
| | Mark Slade | |
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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 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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