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Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer Clinical research trials and Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer. Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer  Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer
Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer
For Condition: Non-small cell lung cancer,Small Cell Lung Cancer
Status: No longer recruiting
Sponsor(s): American College of Radiology Imaging Network , National Cancer Institute (NCI)
Synopsis: 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 computed tomography is more effective than chest x-ray in reducing death from lung cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of helical computed tomography with that of chest x-ray in screening individuals who are at high risk for lung cancer.
Details: OBJECTIVES: Primary: - Determine whether lung cancer 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. Secondary: - Compare all-cause mortality between screenings with CT scan vs chest radiographs. - Compare the differences in stage distribution between the two arms of the study. - Compare lung cancer-related medical resource utilization between the two arms of the study. - Compare the issues of quality of life and psychological impact associated with annual screening and with a positive screening test between the two arms of the study. - Assess the economic consequences of screening with CT scan vs chest radiograph. - Develop a tissue bank from individuals at high risk of lung cancer both with and without pathologically proven lung cancers, which would serve as a resource for determining biomolecular markers of high predictive value in stratifying levels of lung cancer risk, such as pre-malignancy (risk of future development of lung cancer), subclinical lung cancer, and advanced disease. - Assess the impact of screening on smoking behaviors. OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 2 screening arms. Participants undergo spirometry at baseline for assessment of risk profile. - 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. Quality of life is assessed at baseline, 1 month after the screening test, and then every 6 months for up to 6-8 years. Health status and medical resource utilization are assessed every 6-12 months for up to 6-8 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 NLST trial on Cancer.gov. The protocol ID is NCI-NLST. PROJECTED ACCRUAL: A total of 50,000 participants will be accrued for this study within 2 years.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 55 Years/74 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Current or prior cumulative cigarette smoking history of at least 30 pack years (packs per day multiplied by the number of years smoked) - Former smokers must have quit smoking within the past 15 years - No concurrent symptoms suggestive of lung cancer, including the following: - Unexplained weight loss of over 15 pounds within the past 12 months - Unexplained hemoptysis - No prior diagnosis of lung cancer PATIENT CHARACTERISTICS: Age: - 55 to 74 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Pulmonary: - No requirement for home oxygen supplementation - No pneumonia or acute respiratory infection treated with antibiotics within the past 12 weeks Other: - No metallic implants or devices in the chest or back (e.g., pacemakers or Harrington fixation rods) - No medical condition or disability that would pose a significant risk of mortality - No medical or psychiatric condition that would preclude informed consent - No other cancer within the past 5 years except nonmelanoma skin cancer or carcinomas in situ - Melanoma and in situ transitional cell or bladder carcinomas are exclusionary - Able to lie flat on back with arms raised over the head for up to 30 minutes PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 6 months since prior cytotoxic agents for any condition Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - No prior removal of any portion of the lung, excluding percutaneous lung biopsy Other: - At least 18 months since prior chest CT scan - No concurrent participation in another cancer screening trial (e.g., Prostate-Lung-Colorectal-Ovarian Trial or Early Lung Cancer Action Project) - No concurrent participation in a cancer prevention trial other than smoking cessation programs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeniseAberle, Study Chair, Jonsson Comprehensive Cancer Center
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
United States
Roger Williams Medical Center
Providence, Rhode Island, 02908-4735
United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-6838
United States
Emory University School of Medicine
Atlanta, Georgia, 30322
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Beth Israel Deaconess Cancer Center at Waltham
Waltham, Massachusetts, 02453
United States
University of Iowa
Iowa City, Iowa, 52242-1011
United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611
United States
Jewish Hospital
Louisville, Kentucky, 40202-1886
United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, 03756-0002
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
United States
St. Elizabeth Cancer Center at St. Elizabeth Health Center - Youngstown
Youngstown, Ohio, 44501
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000069136; NCI-ACRIN-6654,ACRIN-6654,NCI-NLST-ACRIN-6654
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028808
Other Small Cell Lung Cancer Studies:
1. Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke
2. National Lung Screening Trial (NLST)
3. Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults
4. Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
5. Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers
Related Studies:
Other Small Cell Lung Cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer
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