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Lung CancerPan CanNCT00751660

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

A study testing laboratory biomarker analysis, screening questionnaire administration and bronchoscopic and lung imaging studies in people with Lung Cancer and Tobacco Use Disorder, run by British Columbia Cancer Agency at 6 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Lung Cancer, Tobacco Use Disorder
What is being tested?
laboratory biomarker analysis, screening questionnaire administration and bronchoscopic and lung imaging studies
Type of treatment
Surgery or procedure
How many people
2,504 participants
Where
6 sitesCanada
Study dates
Sep 2008to Mar 2013
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 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • University of Calgary Health Sciences Centre

    Calgary, Alberta, T2N 4N1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • L'Hopital Laval

    Québec, Quebec, G1V 4G5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: 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.

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.

Being tested
laboratory biomarker analysis, screening questionnaire administration, bronchoscopic and lung imaging studies, computed tomography, endoscopic biopsy
Keywords
small cell lung cancer, non-small cell lung cancer, tobacco use disorder
Medical subject headings
Lung Neoplasms, Tobacco Use Disorder, 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.

  • laboratory biomarker analysisOther

  • screening questionnaire administrationOther

  • bronchoscopic and lung imaging studiesProcedure or surgery

  • computed tomographyProcedure or surgery

  • endoscopic biopsyProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 months

  2. Number of interval lung cancer cases

    Measured: 60 months

Secondary outcomes (5)

  1. Stage distribution of lung cancer cases

    Measured: 60 months

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

    Measured: 60 months

  3. Rate of detection of other incidental significant treatable diseases

    Measured: 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

    Measured: 60 months

  5. Potential physical and psychosocial impact on participants

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionMar 2013 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00751660
Sponsor's protocol ID
CDR0000598586
Other IDs
BCCA-H08-01132
Acronym
Pan Can
Status last verified
Mar 2012
First submitted
11 Sep 2008
Last updated
9 Mar 2012
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing laboratory biomarker analysis, screening questionnaire administration and bronchoscopic and lung imaging studies in people with Lung Cancer and Tobacco Use Disorder, run by British Columbia Cancer Agency at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. 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?

Results are not available in the source record.

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?

Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT00751660, which also lists 7 linked publications.

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 9 Mar 2012; AzTrials last refreshed its copy on 31 Oct 2026.

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