A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]
N/A
N/A
Both
Lung Cancer, Precancerous Condition
Trial Information
A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]
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. 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.
Inclusion 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 8 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 ≥ 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Proportion of lung cancer that is diagnosed as stage I or II
Outcome Description:
In the control arm, it is expected that only 15% of cancers will be detected early. In the surveillance arm, we expect that at the time of the first screen, the detection rate of prevalence cancers will be about 3%, from data reported in CT screening studies
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Stephen G. Spiro
Investigator Role:
Study Chair
Investigator Affiliation:
University College London Hospitals
Authority:
United Kingdom: Research Ethics Committee
Study ID:
CDR0000558413
NCT ID:
NCT00512746
Start Date:
August 2007
Completion Date:
Related Keywords:
- Lung Cancer
- Precancerous Condition
- small cell lung cancer
- non-small cell lung cancer
- precancerous condition
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Lung Neoplasms
- Precancerous Conditions
- Lung Diseases, Obstructive
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