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Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer Clinical research trials and Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer. Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer  Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
For Condition: screening for lung cancer,Non-small cell lung cancer,Small Cell Lung Cancer
Status: No longer recruiting
Sponsor(s): Jewish Hospital ,
Synopsis: 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.
Details: 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. PROTOCOL 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 4,000 patients (2,000 per screening arm) will be accrued for this study.
Eligibility:
Study Type: Observational,�Screening
Minimum Age/Maximum Age: 40 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RenatoLaRocca, Study Chair, Jewish Hospital
Jewish Hospital
Louisville, Kentucky, 40202-1886
United States
Additional Information:
Study ID Numbers: CDR0000068079; JHL-45199,NCI-V00-1600
Study Start Date: November 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006087
Other Non-Small Cell Lung Cancer Studies:
1. Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
2. Phase 2 Study of VELCADE Alone or VELCADE® plus Docetaxel in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer
3. A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
4. Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
5. Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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Chest X-ray or Chest CT Scan in Patients at High Risk of Developing Lung Cancer
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