NCT00751660

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,504

participants targeted

Target at P75+ for not_applicable lung-cancer

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

4.5 years

First QC Date

September 11, 2008

Last Update Submit

March 7, 2012

Conditions

Lung CancerTobacco Use Disorder

Keywords

small cell lung cancernon-small cell lung cancertobacco use disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Interventions

laboratory biomarker analysisOTHER
screening questionnaire administrationOTHER
bronchoscopic and lung imaging studiesPROCEDURE
computed tomographyPROCEDURE
endoscopic biopsyPROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

University of Calgary Health Sciences Centre

Calgary, Alberta, T2N 4N1, Canada

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

L'Hopital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (7)

  • 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.

    PMID: 33198781DERIVED

  • 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.

    PMID: 31894702DERIVED

  • 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.

    PMID: 30659040DERIVED

  • 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.

    PMID: 29055736DERIVED

  • 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.

    PMID: 27486205DERIVED

  • 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.

    PMID: 27142184DERIVED

  • 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.

    PMID: 24004118DERIVED

MeSH Terms

Conditions

Lung NeoplasmsTobacco Use DisorderSmall Cell Lung CarcinomaCarcinoma, Non-Small-Cell Lung

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Stephen Lam, MD

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 12, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2013

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

CA(6)