Screening Methods in Finding Lung Cancer Early in Current or Former Smokers (Pan Can)

Early Detection of Lung Cancer - A Pan Canadian Study

RATIONALE: Screening may help doctors find lung cancer sooner, when it may be easier to treat.

PURPOSE: This clinical trial is studying screening methods to see how well they find lung cancer early in current or former smokers.

Study Overview

• Status: Unknown
• Conditions: Tobacco Use Disorder; Lung Cancer
• Intervention / Treatment: Procedure: computed tomography; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Procedure: endoscopic biopsy; Procedure: bronchoscopic and lung imaging studies; Other: screening questionnaire administration

Detailed Description

OBJECTIVES:

• To develop a new multi-modal screening strategy and integrated methods to detect lung cancer early in current and former smokers.
• To evaluate the impact of the screening modalities on the quality of life of these participants.
• To develop a decision analytic framework for determining the cost and effectiveness of a novel lung cancer screening strategy in Canada.

OUTLINE: This is a multicenter study.

Participants undergo spirometry at baseline. Participants also undergo spiral CT scan at baseline and then at 1 and 2 years. Participants with semi-solid or solid nodules of 5-10 mm or ground glass opacity (GGO) 8-10 mm or those with growth of an existing nodule, development of a solid component in GGO, or a new nodule undergo an additional CT scan at 3 months. Some participants also undergo autofluorescence and white light bronchoscopy and bronchial biopsies.

Blood samples are collected at baseline and then annually for 2 years for biomarker studies. Participants diagnosed with lung cancer undergo additional blood sample collection for biomarker studies.

Participants complete questionnaires on sociodemographic factors, smoking, occupational exposure, family history, medical data, quality of life, and anxiety at baseline and then every 6 months for up to 2 years.

• Study Type: Interventional
• Enrollment (Actual): 2504
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • L'Hopital Laval
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary Health Sciences Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency - Vancouver Cancer Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Cancer Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Margaret and Charles Juravinski Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Current or former smoker

  • A former smoker is defined as one who has stopped smoking ≥ 1 year but < 15 years ago
• Estimated 1-year lung cancer risk ≥ 1%

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Not pregnant
• Willing to undergo a spiral chest CT scan
• No severe heart disease (e.g., unstable angina or chronic congestive heart failure)
• No acute or chronic respiratory failure
• No bleeding disorder
• No other medical condition that, in the opinion of the investigator, would preclude the participant's safety during study participation or that would unlikely benefit the participant from screening due to shortened life expectancy from the co-morbidity

• No diagnosis of cancer, except for any of the following that were previously treated ≥ 5 years ago:

  • Non-melanomatous skin cancer
  • Localized prostate cancer
  • Carcinoma in situ of the cervix
  • Superficial bladder cancer
• No known reaction to xylocaine, salbutamol, midazolam, or alfentanil

PRIOR CONCURRENT THERAPY:

• More than 2 years since prior chest CT scan
• No concurrent anti-coagulant treatment (e.g., warfarin or heparin)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy	24 months
Number of interval lung cancer cases	60 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Stage distribution of lung cancer cases	60 months
Prevalence of lung nodules and differences in geographic distribution across Canada	60 months
Rate of detection of other incidental significant treatable diseases	60 months
Type and costs of downstream investigation and treatment related to abnormalities found by the screening procedures, whether the final diagnosis is lung cancer or not	60 months
Potential physical and psychosocial impact on participants	60 months

Collaborators and Investigators

• Sponsor: British Columbia Cancer Agency
• Investigators: Principal Investigator: Stephen Lam, MD, British Columbia Cancer Agency

Publications and helpful links

General Publications

• Zafari Z, Sin DD, Postma DS, Lofdahl CG, Vonk J, Bryan S, Lam S, Tammemagi CM, Khakban R, Man SFP, Tashkin D, Wise RA, Connett JE, McManus B, Ng R, Hollander Z, Sadatsafavi M. Individualized prediction of lung-function decline in chronic obstructive pulmonary disease. CMAJ. 2016 Oct 4;188(14):1004-1011. doi: 10.1503/cmaj.151483. Epub 2016 Aug 2.
• Goffin JR, Pond GR, Puksa S, Tremblay A, Johnston M, Goss G, Nicholas G, Martel S, Bhatia R, Liu G, Schmidt H, Atkar-Khattra S, McWilliams A, Tsao MS, Tammemagi MC, Lam S. Chronic obstructive pulmonary disease prevalence and prediction in a high-risk lung cancer screening population. BMC Pulm Med. 2020 Nov 16;20(1):300. doi: 10.1186/s12890-020-01344-y.
• Rudkowski JL, Pond GR, Tremblay A, Johnston M, Goss G, Nicholas G, Martel S, Bhatia R, Liu G, Schmidt H, Tammemagi MC, Atkar-Khattra S, Tsao MS, Lam S, Goffin JR. Trial marketing in the Pan-Canadian Early Detection of Lung Cancer Study. Clin Trials. 2020 Apr;17(2):202-211. doi: 10.1177/1740774519895966. Epub 2020 Jan 2.
• Taghizadeh N, Tremblay A, Cressman S, Peacock S, McWilliams AM, MacEachern P, Johnston MR, Goffin J, Goss G, Nicholas G, Martel S, Laberge F, Bhatia R, Liu G, Schmidt H, Atkar-Khattra S, Tsao MS, Tammemagi MC, Lam SC; Pan-Canadian Early Lung Cancer Study Group. Health-related quality of life and anxiety in the PAN-CAN lung cancer screening cohort. BMJ Open. 2019 Jan 17;9(1):e024719. doi: 10.1136/bmjopen-2018-024719.
• Tammemagi MC, Schmidt H, Martel S, McWilliams A, Goffin JR, Johnston MR, Nicholas G, Tremblay A, Bhatia R, Liu G, Soghrati K, Yasufuku K, Hwang DM, Laberge F, Gingras M, Pasian S, Couture C, Mayo JR, Nasute Fauerbach PV, Atkar-Khattra S, Peacock SJ, Cressman S, Ionescu D, English JC, Finley RJ, Yee J, Puksa S, Stewart L, Tsai S, Haider E, Boylan C, Cutz JC, Manos D, Xu Z, Goss GD, Seely JM, Amjadi K, Sekhon HS, Burrowes P, MacEachern P, Urbanski S, Sin DD, Tan WC, Leighl NB, Shepherd FA, Evans WK, Tsao MS, Lam S; PanCan Study Team. Participant selection for lung cancer screening by risk modelling (the Pan-Canadian Early Detection of Lung Cancer [PanCan] study): a single-arm, prospective study. Lancet Oncol. 2017 Nov;18(11):1523-1531. doi: 10.1016/S1470-2045(17)30597-1. Epub 2017 Oct 18.
• Tremblay A, Taghizadeh N, McWilliams AM, MacEachern P, Stather DR, Soghrati K, Puksa S, Goffin JR, Yasufuku K, Amjadi K, Nicholas G, Martel S, Laberge F, Johnston M, Shepherd FA, Ionescu DN, Urbanski S, Hwang D, Cutz JC, Sekhon HS, Couture C, Xu Z, Sutedja TG, Atkar-Khattra S, Tammemagi MC, Tsao MS, Lam SC; Pan-Canadian Early Lung Cancer Study Group. Low Prevalence of High-Grade Lesions Detected With Autofluorescence Bronchoscopy in the Setting of Lung Cancer Screening in the Pan-Canadian Lung Cancer Screening Study. Chest. 2016 Nov;150(5):1015-1022. doi: 10.1016/j.chest.2016.04.019. Epub 2016 Apr 30.
• McWilliams A, Tammemagi MC, Mayo JR, Roberts H, Liu G, Soghrati K, Yasufuku K, Martel S, Laberge F, Gingras M, Atkar-Khattra S, Berg CD, Evans K, Finley R, Yee J, English J, Nasute P, Goffin J, Puksa S, Stewart L, Tsai S, Johnston MR, Manos D, Nicholas G, Goss GD, Seely JM, Amjadi K, Tremblay A, Burrowes P, MacEachern P, Bhatia R, Tsao MS, Lam S. Probability of cancer in pulmonary nodules detected on first screening CT. N Engl J Med. 2013 Sep 5;369(10):910-9. doi: 10.1056/NEJMoa1214726.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: September 11, 2008
• First Submitted That Met QC Criteria: September 11, 2008
• First Posted (Estimate): September 12, 2008

Study Record Updates

• Last Update Posted (Estimate): March 9, 2012
• Last Update Submitted That Met QC Criteria: March 7, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; small cell lung cancer; tobacco use disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Tobacco Use Disorder
• Other Study ID Numbers: CDR0000598586; BCCA-H08-01132