- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512746
Screening for Lung Cancer in Current or Past Smokers With Chronic Obstructive Pulmonary Disease
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
England
-
Cambridge, England, United Kingdom, CB23 3RE
- Papworth Hospital
-
Coventry, England, United Kingdom, CV2 2DX
- Walsgrave Hospital
-
Leeds, England, United Kingdom, LS1 3EX
- Leeds General Infirmary
-
Leicester, England, United Kingdom, LE3 9QP
- University Hospitals Of Leicester Nhs Trust
-
London, England, United Kingdom, SW3 6NP
- Royal Brompton Hospital
-
London, England, United Kingdom, SW10 9NH
- Chelsea Westminster Hospital
-
London, England, United Kingdom, WC1E 5DB
- University College Hospital - London
-
Manchester, England, United Kingdom, M23 9LT
- Wythenshawe Hospital
-
Sunderland, England, United Kingdom, SR4 7TP
- Sunderland Royal Hospital
-
-
Northern Ireland
-
Belfast, Northern Ireland, United Kingdom, BT9 7AB
- Respiratory Research Office Belfast City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Control arm
|
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.
|
Other: Surveillance
Screened arm
|
Samples tested and further interventions added if positive
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.
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 Names:
All patients with abnormal sputum cytology and/or cytometry will undergo low dose spiral CT without contrast.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Uptake of screening (the proportion of patients in the surveillance arm who undergo annual screening, among those invited to attend)
Time Frame: 5 Years
|
5 Years
|
Proportion of patients in the surveillance arm who have abnormal sputum cytology
Time Frame: 5 Years
|
5 Years
|
Proportion of patients in the surveillance arm who have abnormal sputum cytometry
Time Frame: 5 Years
|
5 Years
|
Death from lung cancer
Time Frame: Up to 15 years
|
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
|
5 Years
|
Prevalence of pre-invasive disease in patients in the surveillance arm with abnormal cytometry
Time Frame: 5 Years
|
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
|
5 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stephen G. Spiro, University College London Hospitals
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000558413
- CRUK-BRD/06/10
- EU-20738
- ISRCTN80745975
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Cancer
-
M.D. Anderson Cancer CenterRecruitingStage III Lung Cancer AJCC v8 | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingStage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
Dana-Farber Cancer InstituteMedWaves, IncNot yet recruitingLung Cancer | Lung Cancer Stage I | Lung Cancer Stage II | Stage I Lung Cancer | Stage I - II Primary Lung Cancer | Stage II Lung CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingCaregiver | Stage III Lung Cancer AJCC v7 | Stage I Lung Cancer AJCC v7 | Stage II Lung Cancer AJCC v7 | Stage IB Lung Cancer AJCC v7 | Stage IA Lung Cancer AJCC v7 | Stage IIA Lung Cancer AJCC v7 | Stage IIB Lung Cancer AJCC v7 | Stage IIIA Lung Cancer AJCC v7 | Stage IIIB Lung Cancer AJCC v7United States
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung... and other conditionsUnited States
-
Emory UniversityNational Cancer Institute (NCI)TerminatedLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
University of California, San FranciscoMerck Sharp & Dohme LLCWithdrawnLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Metastatic Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Head and Neck Carcinoma | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung... and other conditionsUnited States
Clinical Trials on cytology and cytometry specimen collection procedure
-
Jonsson Comprehensive Cancer CenterRecruitingMalignant NeoplasmUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)Recruiting
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedOsteosarcomaUnited States, Canada, Australia, New Zealand, Puerto Rico
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | Small Lymphocytic Lymphoma | Lymphoproliferative Disorder | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Grade 3 Follicular... and other conditionsUnited States, Canada, Australia, Puerto Rico
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung Carcinoma | Lung Neoplasm | Malignant Lung NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Childhood Medulloblastoma | Recurrent Childhood Ependymoma | Childhood Atypical Teratoid/Rhabdoid Tumor | Ependymoma | Childhood Craniopharyngioma | Childhood Grade I Meningioma | Childhood Grade II Meningioma | Childhood Grade III Meningioma | Childhood Infratentorial Ependymoma | Childhood... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
National Cancer Institute (NCI)RecruitingMalignant Solid Neoplasm | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Hematopoietic and Lymphatic System NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRefractory Childhood Hodgkin Lymphoma | Ann Arbor Stage I Childhood Hodgkin Lymphoma | Ann Arbor Stage II Childhood Hodgkin Lymphoma | Ann Arbor Stage III Childhood Hodgkin Lymphoma | Ann Arbor Stage IV Childhood Hodgkin LymphomaUnited States, Canada, Australia, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedJuvenile Myelomonocytic Leukemia | Chronic Lymphocytic Leukemia | Secondary Acute Myeloid Leukemia | Childhood Acute Lymphoblastic Leukemia | Prolymphocytic Leukemia | Hairy Cell Leukemia | Acute Undifferentiated Leukemia | Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative | Childhood Acute Myeloid... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI)RecruitingLymphoma | Myelodysplastic Syndromes | Leukemia | Chronic Myeloproliferative Disorders | Multiple Myeloma and Plasma Cell Neoplasm | Nonmalignant Neoplasm | Lymphoproliferative Disorder | Myelodysplastic/Myeloproliferative NeoplasmsUnited States