RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for lung cancer. It is not yet known whether helical CT scan is more effective than chest x-ray in reducing death from lung cancer.

PURPOSE: Randomized clinical trial to compare the effectiveness of helical CT scan with that of chest x-ray in screening individuals who are at high risk for developing lung cancer.

Condition	Treatment or Intervention
Small Cell Lung Cancer Non-small cell lung cancer	Procedure: bronchoscopic and lung imaging studies  Procedure: comparison of screening methods  Procedure: screening intervention

Further Study Details: 

OBJECTIVES:

• Compare whether screening with low-dose helical CT scan vs chest x-ray reduces lung cancer-specific mortality in participants who are at high risk for developing lung cancer.

OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 2 screening arms.

• Arm I: Participants undergo helical CT scan.
• Arm II: Participants undergo chest x-ray. Participants in both arms undergo screening initially and then annually for 2 years.

Participants will then be contacted annually by mail or telephone for several years.

The National Lung Screening Trial (NLST) represents the union of two NCI-sponsored activities, the NCI Lung Screening Study I and the American College of Radiology Imaging Network (ACRIN). For more information, please access the ACRIN trial on Cancer.gov. The protocol ID is ACRIN-6654.

PROJECTED ACCRUAL: A total of 50,000 participants will be accrued for this study within 2 years.

Ages Eligible for Study:  55 Years   -   74 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Heavy smoker or former smoker (quit within last 15 years)
• No prior cancer (other than nonmelanoma skin cancer or in situ cancer) within past 5 years

PATIENT CHARACTERISTICS: Age

• 55 to 74

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35233,  United States
California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States
Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80262,  United States
District of Columbia
      Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States
Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States
Hawaii
      Pacific Health Research Institute, Honolulu,  Hawaii,  96813,  United States
Idaho
      Mountain States Tumor Institute - Boise, Boise,  Idaho,  83712,  United States
Illinois
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611,  United States
Iowa
      University of Iowa, Iowa City,  Iowa,  52242-1011,  United States
Kentucky
      Jewish Heart and Lung Institute, Louisville,  Kentucky,  40202,  United States
      Jewish Hospital, Louisville,  Kentucky,  40202-1886,  United States
Louisiana
      Alton Ochsner Medical Foundation Hospital, New Orleans,  Louisiana,  70121,  United States
      Ochsner Clinic Foundation, New Orleans,  Louisiana,  70121,  United States
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
Michigan
      Josephine Ford Cancer Center at Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0942,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Missouri
      Mallinckrodt Institute of Radiology, St. Louis,  Missouri,  63108,  United States
New Hampshire
      Norris Cotton Cancer Center at Dartmouth Medical School, Lebanon,  New Hampshire,  03756-0002,  United States
New Jersey
      Cancer Institute of New Jersey at Hamilton, Hamilton,  New Jersey,  08690,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
Ohio
      St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown, Youngstown,  Ohio,  44501,  United States
Pennsylvania
      Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia,  Pennsylvania,  19104,  United States
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15236,  United States
Rhode Island
      Roger Williams Medical Center, Providence,  Rhode Island,  02908-4735,  United States
South Carolina
      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States
Tennessee
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6838,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States
Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84112,  United States
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States

Study chairs or principal investigators

John K. Gohagan, PhD, FACE,  Study Chair,  National Cancer Institute (NCI)   
Denise R. Aberle, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000257938; NCI-NLST; ACRIN-NCI-NLST
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  October 3, 2002
ClinicalTrials.gov Identifier:  NCT00047385
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08