IRB Number:

689-02

Trial Status:

Closed

Phase: I

Why is this study being done?

Purpose of the Study

To compare two ways of detecting lung cancer: digital chest X-ray and spiral computed tomography (CT) scan. This study aims to show which of these tests is best at detecting lung cancer at an early stage.

Abstract

Lung cancer is now the most common cause of cancer death among women and men. Despite considerable clinical research in multi-modality cancer treatment, there has been no significant decrease in lung cancer-specific mortality over the past three decades. Approximately 80% of lung cancers are of non-small cell histology, for which prognosis depends primarily upon tumor stage at the time of diagnosis. Although overall survival rates with non-small cell carcinoma are dismal, patients with surgical stage I disease may have 10-year survivals of up to 70%. This has formed the rationale for early detection programs. Previous large screening trials using combinations of chest radiographs and sputum cytology showed no significant improvement in lung cancer-specific or all-cause mortality among screened high-risk cohorts. However, contemporary computed tomography (CT) offers the potential to detect lung cancers at early stages amenable to surgical cure. This project involves using a multicenter, randomized controlled trial of 10,000 individuals at high risk of developing lung cancer to see whether screening with low-dose helical CT can reduce lung cancer-specific mortality relative to chest radiographs. A secondary objective is to create a bank of specimens from well-characterized high-risk cohorts that can be used to test future potential biomolecular markers of lung cancer. High risk will be defined by age 55-74 years with a current or previous heavy smoking history equaling at least 30 pack years; former smokers must have quit within the preceding 15 years. Prior to randomization, standardized eligibility, health, sociodemographic, and quality of life questionnaires as well as spirometry will be performed. Both Experimental and Control participants will provide blood, sputum and urine samples for archive at study entry and at the time of the first and second incidence screen. The Experimental group will undergo screening with low dose helical CT. The Control group will undergo screening with chest radiographs. Both groups will be screened annually for at least two incidence screens. Both groups will be contacted at six-month intervals to document interval health status and annually to complete quality of life questionnaires. Subgroups of both cohorts will complete questionnaires to determine the differential psychological impact of screening for lung cancer. Similarly, subgroups of Experimental and Control participants who have positive screening results will complete questionnaires to determine the psychological impact of positive screening tests, using as case-matched controls subgroups of Control and Experimental participants with negative screening CT results. The primary end-point of the trial is lung cancer-specific mortality. Intermediate end-points will include all-cause mortality; surgical stage at diagnosis; medical resource utilization; the impact of screening on quality of life and psychological effects; and the economic consequences of helical CT screening.

Who is Eligible to Participate in the Study?

• Healthy men and women aged 55 to 74
  
• Current or former smokers who have smoked heavily, or have smoked for many years
  
• People who have never had lung cancer
  
• People who are not being treated for any type of cancer
  
• People who are not participating in another cancer screening or cancer prevention trial

Minimum Age:

55

Maximum Age:

74

Additional Requirements / Information

• Medical history
  
• Lung function testing
  
• Patient questionnaires
  
• Blood draw, urine, and sputum samples
  
• Low-dose spiral CT scan or digital chest X-ray at baseline and annually for 2 years
  
• Interim contacts by mail or telephone

Benefits

• No charge for study-related tests
  
• Test results made available to participants and their physicians
  
• Monetary compensation for travel and time away from work or home
  
• Free parking on study days

Study Team


S.J. Swensen, M.D., Principal Investigator, Radiology

T.E. Hartman, M.D., Co-Investigator, Radiology

J.R. Jett, M.D., Co-Investigator, Pulmonary & Critical Care Medicine

D.E. Midthun, M.D., Co-Investigator, Pulmonar

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
At Mayo Clinic Rochester:

Pulmonary Clinical Research Center

1-888-885-7503 or 507-266-1190




At Mayo Clinic Jacksonville:

Barbara McComb, M.D.

Principal Investigator

904-953-8538

Or

Elizabeth Johnson, M.D.

Co-Principal Investigator

904-953-2200

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL

Last updated: 05/11/2009