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

Primary Purpose

Lung Cancer, Tobacco Use Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
laboratory biomarker analysis
screening questionnaire administration
bronchoscopic and lung imaging studies
computed tomography
endoscopic biopsy
quality-of-life assessment
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring small cell lung cancer, non-small cell lung cancer, tobacco use disorder

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Calgary Health Sciences Centre
  • British Columbia Cancer Agency - Vancouver Cancer Centre
  • Nova Scotia Cancer Centre
  • Margaret and Charles Juravinski Cancer Centre
  • Princess Margaret Hospital
  • L'Hopital Laval

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stage distribution of lung cancer cases
Prevalence of lung nodules and differences in geographic distribution across Canada
Rate of detection of other incidental significant treatable diseases
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
Potential physical and psychosocial impact on participants

Full Information

First Posted
September 11, 2008
Last Updated
March 7, 2012
Sponsor
British Columbia Cancer Agency
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1. Study Identification

Unique Protocol Identification Number
NCT00751660
Brief Title
Screening Methods in Finding Lung Cancer Early in Current or Former Smokers
Acronym
Pan Can
Official Title
Early Detection of Lung Cancer - A Pan Canadian Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Tobacco Use Disorder
Keywords
small cell lung cancer, non-small cell lung cancer, tobacco use disorder

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2504 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
screening questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
bronchoscopic and lung imaging studies
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
endoscopic biopsy
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy
Time Frame
24 months
Title
Number of interval lung cancer cases
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Stage distribution of lung cancer cases
Time Frame
60 months
Title
Prevalence of lung nodules and differences in geographic distribution across Canada
Time Frame
60 months
Title
Rate of detection of other incidental significant treatable diseases
Time Frame
60 months
Title
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
Title
Potential physical and psychosocial impact on participants
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Lam, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary Health Sciences Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
L'Hopital Laval
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33198781
Citation
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.
Results Reference
derived
PubMed Identifier
31894702
Citation
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.
Results Reference
derived
PubMed Identifier
30659040
Citation
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.
Results Reference
derived
PubMed Identifier
29055736
Citation
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.
Results Reference
derived
PubMed Identifier
27486205
Citation
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.
Results Reference
derived
PubMed Identifier
27142184
Citation
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.
Results Reference
derived
PubMed Identifier
24004118
Citation
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.
Results Reference
derived

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

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