Lung Cancer Clinical Trial; Screening Methods in Finding Lung Cancer Early in Current or Former Smokers

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Screening Methods in Finding Lung Cancer Early in Current or Former Smokers
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsored by: British Columbia Cancer Agency

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00751660

Purpose
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.



Condition Intervention
Cancer-Related Problem/Condition
Lung Cancer
Other: laboratory biomarker analysis
Other: screening questionnaire administration
Procedure: bronchoscopic and lung imaging studies
Procedure: computed tomography
Procedure: endoscopic biopsy
Procedure: quality-of-life assessment




MedlinePlus related topics: CT Scans Cancer Lung Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening, Open Label
Official Title: Early Detection of Lung Cancer - A Pan Canadian Study


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Number of lung cancer cases detected early by spiral CT scan and autofluorescence bronchoscopy [ Designated as safety issue: No ]

Number of interval lung cancer cases [ Designated as safety issue: No ]

Stage distribution of lung cancer cases [ Designated as safety issue: No ]

Prevalence of lung nodules and differences in geographic distribution across Canada [ Designated as safety issue: No ]

Rate of detection of other incidental significant treatable diseases [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]

Potential physical and psychosocial impact on participants [ Designated as safety issue: No ]

Adverse events [ Designated as safety issue: Yes ]

Logistics/barriers for an early detection program [ Designated as safety issue: No ]


Estimated Enrollment: 2500
Study Start Date: September 2008
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.

Eligibility


Ages Eligible for Study: 50 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Current or former smoker

A former smoker is defined as one who has stopped smoking &#8805; 1 year but < 15 years ago
Estimated 1-year lung cancer risk &#8805; 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 &#8805; 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)
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751660


Locations
Canada
L'Hopital Laval Recruiting
Quebec, Canada, G1V 4G5
Contact: Contact Person 418-656-4810
Canada, Alberta
University of Calgary Health Sciences Centre Recruiting
Calgary, Alberta, Canada, T2N 4N1
Contact: Contact Person 403-944-1744
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Stephen Lam, MD 604-675-8089
Canada, Nova Scotia
Nova Scotia Cancer Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Contact Person 902-473-1913
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Contact Person 905-387-9495
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Contact Person 416-946-4501 ext 6318

Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Stephen Lam, MD British Columbia Cancer Agency

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000598586, BCCA-H08-01132
Study First Received: September 11, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00751660 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
small cell lung cancer
non-small cell lung cancer
tobacco use disorder



Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Signs and Symptoms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Tobacco Use Disorder
Carcinoma, Non-Small-Cell Lung



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms



ClinicalTrials.gov processed this record on February 10, 2009


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