Chest X-Ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer

February 6, 2009 updated by: Jewish Hospital and St. Mary's Healthcare

A Randomized Prospective Study Comparing Annual Chest X-Rays to Annual Spiral Chest CT Scanning in Patients at High-Risk for the Development of Lung Cancer

RATIONALE: Diagnostic procedures such as chest x-ray and chest CT scans may be effective in early detection of lung cancer.

PURPOSE: Randomized clinical trial to compare the effectiveness of a chest CT scan given once a year with that of a chest x-ray given once a year in detecting lung cancer in patients at a high-risk of developing lung cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the efficacy of a lung cancer risk assessment questionnaire combined with spirometry testing in identifying a statistically significant number of persons with high-risk behaviors for the development of lung cancer. II. Determine the sensitivity of these screening techniques in identifying a population at high risk for the development of lung cancer. III. Determine the number of patients necessary to screen in order to identify the high-risk population eligible for this study. IV. Determine the lead time bias of CT scans versus chest x-rays in these patients. V. Determine the efficacy of spiral CT scanning of the chest in detecting early lung cancers not visible on chest x-rays in patients at high risk for lung cancer. VI. Compare annual spiral CT scanning versus annual chest x-rays in detecting lung cancer in these patients. VII. Compare survival and fatality in these patients with these detection methods.

OUTLINE: Patients are randomized to one of two screening arms. Arm I: Patients receive routine medical care, an annual nursing assessment, and an annual chest x-ray. Any new abnormality identified is further evaluated through standard acceptable medical interventions. Arm II: Patients receive routine medical care, an annual nursing assessment, and an annual spiral CT scan of the chest. If an abnormal mass greater than 10 mm in diameter or 5-10 mm in diameter and highly suspicious for malignancy is detected, chest x-ray and tissue diagnosis is obtained. If the abnormal mass is 10 mm or less in diameter, a thin section high resolution image of the mass is obtained. If this image is normal or benign, annual spiral CT scanning is continued. If the image is indeterminate, a repeat high resolution scan is performed in 3 months. If the image is unchanged at 3 months, annual spiral CT scanning is continued. If the mass is larger at 3 months, chest x-ray and tissue diagnosis is performed. Screening continues for 5 years in the absence of disease detection.

PROJECTED ACCRUAL: A minimum of 1,000 patients (500 per screening arm) will be accrued for this study.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202-1886
        • Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Patients at high risk for the development of lung cancer as defined by the following: At least 40 pack years smoking (may have stopped smoking within past 10 years) at time of study entry FEV-1/FVC ratio less than 70% predicted OR FEV-1 less than 80% predicted obtained from 3 serial performances with less than 5% difference Normal or stable current chest x-ray

PATIENT CHARACTERISTICS: Age: 40 to 70 Performance status: Not specified Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: See Disease Characteristics Other: No other comorbidity that limits life span to less than 5 years No prior cancer except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jewish Hospital and St. Mary's Healthcare

Investigators

  • Study Chair: Renato V. LaRocca, MD, FACP, Kentuckiana Cancer Institute, PLLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

December 22, 2003

First Posted (Estimate)

December 23, 2003

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068079
  • JHL-45199
  • NCI-V00-1600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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