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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00512746
First received: August 6, 2007
Last updated: December 20, 2011
Last verified: December 2011
  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 Condition
Other: cytology and cytometry specimen collection procedure
Other: Chest x ray
Procedure: Autofluorescence bronchoscopy
Procedure: CT scan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Proportion of lung cancer that is diagnosed as stage I or II [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend) [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Proportion of patients in the surveillance arm who have abnormal sputum cytology [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Proportion of patients in the surveillance arm who have abnormal sputum cytometry [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Death from lung cancer [ Time Frame: Up to 15 years ] [ Designated as safety issue: No ]
  • Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples) [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry [ Time Frame: 5 Years ] [ 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 [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Enrollment: 1569
Study Start Date: August 2007
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surveillance
Screened arm
Other: cytology and cytometry specimen collection procedure
Samples tested and further interventions added if positive
Other: Chest x ray
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years. This could help identify a lung cancer that may not have been associated with symptoms earlier.
Procedure: Autofluorescence bronchoscopy
The bronchial tree will be inspected first under white light and then under blue light. All areas that appear abnormal will initially be documented and only sampled when the bronchoscopic examination has been completed.
Other Name: AFB
Procedure: CT scan
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
Active Comparator: Control
Control arm
Other: Chest x ray
Patients not diagnosed with lung cancer during the course of the study, will be offered an exit chest x-ray after 5 years or sooner if they withdraw from the trial before 5 years. This could help identify a lung cancer that may not have been associated with symptoms earlier.

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. 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Papworth Hospital
Cambridge, England, United Kingdom, CB23 3RE
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX
University Hospitals of Leicester NHS Trust
Leicester, England, United Kingdom, LE3 9QP
Chelsea Westminster Hospital
London, England, United Kingdom, SW10 9NH
Royal Brompton Hospital
London, England, United Kingdom, SW3 6NP
University College Hospital - London
London, England, United Kingdom, WC1E 5DB
Wythenshawe Hospital
Manchester, England, United Kingdom, M23 9LT
Sunderland Royal Hospital
Sunderland, England, United Kingdom, SR4 7TP
Respiratory Research Office Belfast City Hospital
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Sponsors and Collaborators
University College, London
Investigators
Study Chair: Stephen G. Spiro University College London Hospitals
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00512746     History of Changes
Other Study ID Numbers: CDR0000558413, CRUK-BRD/06/10, EU-20738, ISRCTN80745975
Study First Received: August 6, 2007
Last Updated: December 20, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
small cell lung cancer
non-small cell lung cancer
precancerous condition

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Neoplasms
Precancerous Conditions
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014