CClinicalTrials.gg
Status unknownNCT00751660Pan CanUpdated Mar 9, 2012

Screening Methods in Finding Lung Cancer Early in Current or Former Smokers

An interventional study of laboratory biomarker analysis and screening questionnaire administration in Lung Cancer and Tobacco Use Disorder, sponsored by British Columbia Cancer Agency. Status unknown at 6 sites in Canada. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-03-09.

Sponsored by British Columbia Cancer Agency · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,504
Allocation
Not applicable
Ages
50 Years to 75 Years
Sex
All
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Study summary

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.

Read the 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.

02

Conditions studied

  • Lung Cancer
  • Tobacco Use Disorder

Keywords

  • small cell lung cancer
  • non-small cell lung cancer
  • tobacco use disorder
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 2,504 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,504 participants (actual)

Interventions

  • Otherlaboratory biomarker analysis
  • Otherscreening questionnaire administration
  • Procedurebronchoscopic and lung imaging studies
  • Procedurecomputed tomography
  • Procedureendoscopic biopsy
  • Procedurequality-of-life assessment
06

What researchers measure

Primary outcomes

  1. Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy

    Time frame: 24 months

  2. Number of interval lung cancer cases

    Time frame: 60 months

Secondary outcomes

  1. Stage distribution of lung cancer cases

    Time frame: 60 months

  2. Prevalence of lung nodules and differences in geographic distribution across Canada

    Time frame: 60 months

  3. Rate of detection of other incidental significant treatable diseases

    Time frame: 60 months

  4. 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

    Time frame: 60 months

  5. Potential physical and psychosocial impact on participants

    Time frame: 60 months

07

Study locations

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

Publications

  • 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. PubMed 33198781 ↗
  • 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. PubMed 31894702 ↗
  • 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. PubMed 30659040 ↗
  • 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. PubMed 29055736 ↗
  • 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. PubMed 27486205 ↗
  • 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. PubMed 27142184 ↗
  • 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. PubMed 24004118 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00751660
Lead sponsor
British Columbia Cancer Agency
Responsible party
Sponsor
First posted
Sep 12, 2008
Start date
Sep 2008
Primary completion
Mar 2013 (estimated)
Last update
Mar 9, 2012

Study contacts

Stephen Lam, MD
principal investigator · British Columbia Cancer Agency

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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