Lung CancerNCT00512746
Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
A study testing cytology and cytometry specimen collection procedure, Chest x ray and Autofluorescence bronchoscopy in people with Lung Cancer and Precancerous Condition, run by University College, London at 10 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Precancerous Condition
- What is being tested?
- cytology and cytometry specimen collection procedure, Chest x ray and Autofluorescence bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,569 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- Aug 2007to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Life expectancy must be at least 5 years
Who cannot join
- Inadequate lung function (FEV_1 < 50% of predicted after bronchodilator)
- PATIENT CHARACTERISTICS:
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Respiratory Research Office Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB
Papworth Hospital
Cambridge, England, CB23 3RE
Walsgrave Hospital
Coventry, England, CV2 2DX
Leeds General Infirmary
Leeds, England, LS1 3EX
University Hospitals of Leicester NHS Trust
Leicester, England, LE3 9QP
Chelsea Westminster Hospital
London, England, SW10 9NH
Royal Brompton Hospital
London, England, SW3 6NP
University College Hospital - London
London, England, WC1E 5DB
Wythenshawe Hospital
Manchester, England, M23 9LT
Sunderland Royal Hospital
Sunderland, England, SR4 7TP
About this study
Official title: A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]
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.
Read the 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.
- Conditions
- Lung Cancer, Precancerous Condition
- Being tested
- cytology and cytometry specimen collection procedure, Chest x ray, Autofluorescence bronchoscopy, CT scan
- Keywords
- small cell lung cancer, non-small cell lung cancer, precancerous condition
- Medical subject headings
- Lung Neoplasms, Precancerous Conditions, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytology and cytometry specimen collection procedureOther
Samples tested and further interventions added if positive
Chest x rayOther
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.
Autofluorescence bronchoscopyProcedure or surgery
Also called AFB
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.
CT scanProcedure or surgery
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
| Study group | Role | What they receive |
|---|---|---|
| Surveillance | Other | Screened arm Receives: Other: cytology and cytometry specimen collection procedure; Other: Chest x ray; Procedure: Autofluorescence bronchoscopy; Procedure: CT scan |
| Control | Active comparator | Control arm Receives: Other: Chest x ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 5 Years
Proportion of patients in the surveillance arm who have abnormal sputum cytology
Measured: 5 Years
Proportion of patients in the surveillance arm who have abnormal sputum cytometry
Measured: 5 Years
Death from lung cancer
Measured: Up to 15 years
Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples)
Measured: 5 Years
Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry
Measured: 5 Years
Number of patients in the surveillance arm with pre-invasive lesions who develop lung cancer locally and at remote sites within the lung
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,569 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen G. Spiro, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512746
- Sponsor's protocol ID
- CDR0000558413
- Other IDs
- CRUK-BRD/06/10, EU-20738, ISRCTN80745975
- Status last verified
- Dec 2011
- First submitted
- 6 Aug 2007
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26138736
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Surveillance for the Early Detection of Lung Cancer in an at Risk Group [Lung-SEARCH Trial]
- ClinicalTrials.gov ID
- NCT00512746
- Acronym / sponsor ID
- CDR0000558413
- Conditions
- Lung Cancer, Precancerous Condition
- Keywords
- small cell lung cancer, non-small cell lung cancer, precancerous condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,569 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Mar 2011 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance | Other | Other: cytology and cytometry specimen collection procedure, Other: Chest x ray, Procedure: Autofluorescence bronchoscopy, Procedure: CT scanScreened arm |
| Control | Active comparator | Other: Chest x rayControl arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Meets 1 of the following criteria:
- Mild to moderate chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria
- Life expectancy must be at least 5 years
Key exclusion criteria (9 listed)
- Inadequate lung function (FEV_1 < 50% of predicted after bronchodilator)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytology and cytometry specimen collection procedureSamples tested and further interventions added if positive | Other | Surveillance |
| Chest x rayPatients 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. | Other | Control, Surveillance |
| Autofluorescence bronchoscopyAlso: AFBThe 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. | Procedure or surgery | Surveillance |
| CT scanAll patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast. | Procedure or surgery | Surveillance |
Primary outcome
Proportion of lung cancer that is diagnosed as stage I or II
Time frame: 5 years
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
7 secondary outcomes
Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)
Time frame: 5 Years
Proportion of patients in the surveillance arm who have abnormal sputum cytology
Time frame: 5 Years
Proportion of patients in the surveillance arm who have abnormal sputum cytometry
Time frame: 5 Years
Death from lung cancer
Time frame: Up to 15 years
Proportion of failed sputum samples (i.e., where it is not possible to obtain adequate sputum samples)
Time frame: 5 Years
Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry
Time frame: 5 Years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
- Derived from this study: PubMed 26138736Spiro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen G. Spiro study chair
University College London Hospitals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cytology and cytometry specimen collection procedure, Chest x ray and Autofluorescence bronchoscopy in people with Lung Cancer and Precancerous Condition, run by University College, London at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of lung cancer that is diagnosed as stage I or II (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00512746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2011.