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

NCT00512746 | Completed DMC

• 4 other identifiers: CDR0000558413CRUK-BRD/06/10EU-20738ISRCTN80745975
• Study Type: interventional
• Target: 1,569
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Lung Cancer; Precancerous Condition

Keywords

small cell lung cancer; non-small cell lung cancer; precancerous condition

Outcome Measures

Primary Outcomes (1)

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

  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

  5 years

Secondary Outcomes (7)

• Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)

  5 Years

• Proportion of patients in the surveillance arm who have abnormal sputum cytology

  5 Years

• Proportion of patients in the surveillance arm who have abnormal sputum cytometry

  5 Years

• Death from lung cancer

  Up to 15 years

• Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples)

  5 Years

Study Arms (2)

Surveillance

OTHER

Screened arm

Other: cytology and cytometry specimen collection procedure; Other: Chest x ray; Procedure: Autofluorescence bronchoscopy; Procedure: CT scan

Control

ACTIVE COMPARATOR

Control arm

Other: Chest x ray

Interventions

cytology and cytometry specimen collection procedure OTHER

Samples tested and further interventions added if positive

Surveillance

Chest x ray OTHER

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.

Control; Surveillance

Autofluorescence bronchoscopy PROCEDURE

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.

Also known as: AFB

Surveillance

CT scan PROCEDURE

All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.

Surveillance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inadequate lung function (FEV\_1 \< 50% of predicted after bronchodilator)
• PATIENT CHARACTERISTICS:
• Life expectancy must be at least 5 years
• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (10)

Papworth Hospital

Cambridge, England, CB23 3RE, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, England, LE3 9QP, United Kingdom

Location

Chelsea Westminster Hospital

London, England, SW10 9NH, United Kingdom

Location

Royal Brompton Hospital

London, England, SW3 6NP, United Kingdom

Location

University College Hospital - London

London, England, WC1E 5DB, United Kingdom

Location

Wythenshawe Hospital

Manchester, England, M23 9LT, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, England, SR4 7TP, United Kingdom

Location

Respiratory Research Office Belfast City Hospital

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Related Publications (1)

• Spiro SG, Hackshaw A; LungSEARCH Collaborative Group. Research in progress--LungSEARCH: a randomised controlled trial of surveillance for the early detection of lung cancer in a high-risk group. Thorax. 2016 Jan;71(1):91-3. doi: 10.1136/thoraxjnl-2015-207433. Epub 2015 Jul 2.

  PMID: 26138736 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Precancerous Conditions; Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Cytological Techniques; X-Rays

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Stephen G. Spiro

  University College London Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2011
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

GB (10)