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Chest X-Ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: August 3, 2000   Last Updated: February 6, 2009   History of Changes
Sponsor: Jewish Hospital, Louisville, Kentucky
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006087
  Purpose

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.


Condition Intervention
Lung Cancer
Procedure: annual screening
Procedure: bronchoscopic and lung imaging studies
Procedure: comparison of screening methods
Procedure: computed tomography
Procedure: radiography
Procedure: study of high risk factors

Study Type: Interventional
Study Design: Screening
Official Title: 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

Resource links provided by NLM:


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

Study Start Date: November 1999
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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006087

Locations
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202-1886
Sponsors and Collaborators
Jewish Hospital, Louisville, Kentucky
Investigators
Study Chair: Renato V. LaRocca, MD, FACP Kentuckiana Cancer Institute, PLLC
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068079, JHL-45199, NCI-V00-1600
Study First Received: August 3, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006087     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on November 27, 2009