Lung Screening Study

Lung Cancer Clinical Trial

Official title:

Lung Screening Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006382
• Other study ID #: CDR0000068258
• Secondary ID: NCI-LUNGNCI-P00-
• Status: Completed
• Phase: N/A
• First received: October 4, 2000
• Last updated: May 1, 2015
• Start date: August 2000
• Est. completion date: December 2002

Study information

• Verified date: June 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: New imaging procedures such as spiral CT may improve the ability to detect lung cancer in patients who are at high risk for the disease.

PURPOSE: Randomized clinical trial to compare the effectiveness of a spiral CT scan with that of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.

Description:

OBJECTIVES: I. Compare the efficacy of screening spiral CT scan and screening chest x-ray in detecting lung cancer in current or former smokers at high risk for lung cancer.

OUTLINE: This is a randomized, multicenter study of lung cancer screening. Patients are randomized to one of two screening arms. Arm I: Patients undergo one spiral CT scan. Arm II: Patients undergo one chest x-ray. Patients and their primary care physicians are notified of test results within 3 weeks of the exam.

PROJECTED ACCRUAL: A total of 3,000 participants (1,500 per screening arm) will be accrued for this study at six screening centers (500 per center) by October 31, 2000.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 74 Years

Eligibility

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: Age: 55 to 74 Patients with a cigarette smoking history of at least 30 pack-years Current smoker OR Smoker who has quit smoking within the past 10 years No known prior history of lung cancer

PRIOR CONCURRENT THERAPY: No concurrent therapy for any cancer except nonmelanomatous skin cancer No prior removal of any portion of the lungs No concurrent participation in other cancer screening trial, including PLCO No concurrent participation in a primary cancer prevention trial other than a smoking cessation trial

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• bronchoscopic and lung imaging studies

• comparison of screening methods

• computed tomography

• radiography

• study of high risk factors

Locations

Country	Name	City	State
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Henry Ford Hospital	Detroit	Michigan
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Vincent T. Lombardi Cancer Research Center, Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Croswell JM, Baker SG, Marcus PM, Clapp JD, Kramer BS. Cumulative incidence of false-positive test results in lung cancer screening: a randomized trial. Ann Intern Med. 2010 Apr 20;152(8):505-12, W176-80. doi: 10.7326/0003-4819-152-8-201004200-00007. Erra — View Citation

Gohagan J, Marcus P, Fagerstrom R, Pinsky P, Kramer B, Prorok P; Writing Committee, Lung Screening Study Research Group. Baseline findings of a randomized feasibility trial of lung cancer screening with spiral CT scan vs chest radiograph: the Lung Screeni — View Citation