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Computed Tomography for Early Detection of Cancer in Women Who Are at 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 Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer Clinical research trials and Computed Tomography for Early Detection of Cancer in Women Who Are at 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 Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer. Computed Tomography for Early Detection of Cancer in Women Who Are at 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 Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Computed Tomography for Early Detection of Cancer in Women Who Are at 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 > "C" Clinical Trials Conditions > Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer  Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
For Condition: Non-small cell lung cancer,Small Cell Lung Cancer
Status: No longer recruiting
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imaging procedures such as computed tomography may improve the ability to detect lung cancer earlier. PURPOSE: Screening and diagnostic study of computed tomography in women who are at risk for lung cancer.
Details: OBJECTIVES: - Determine the ability of computed tomography (CT) to detect early lung parenchymal abnormalities in women at high risk for lung cancer. - Determine the number of abnormal findings detected by CT that develop into lung cancer in these patients. - Correlate these abnormalities with the presence of K-ras and p53 mutations in the sputum and bronchoalveolar lavage in these patients. - Develop and implement appropriate educational materials regarding lung cancer in women and provide referrals to other programs, such as smoking cessation programs. OUTLINE: Patients complete a questionnaire at baseline to assess demographics, medical history, smoking history, menopausal status, estrogen therapy, and diet. Patients then undergo a low-dose computed tomography (CT) scan without contrast. Patients with normal CT results undergo additional CT scans every 12 months. Patients with abnormal CT results undergo a diagnostic CT scan (in the absence of prior studies). Patients with indeterminate nodules (less than 5 mm in size) undergo surveillance CT studies within 3-4 months. If nodules remain unchanged in size, patients undergo additional surveillance CT studies at 6 months and 1 year. Patients with lung parenchymal abnormalities on CT suspicious for malignancy undergo a bronchoscopy with biopsy and bronchoalveolar lavage (BAL). Patients with abnormal CT scan(s) and negative BAL for p53 and/or K-ras mutations or normal histology and positive BAL for K-ras and/or p53 mutations undergo additional CT scans at 6 months and 1 year. Patients with biopsy-proven malignancy after bronchoscopy are referred for definitive treatment. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Women who currently smoke or have smoking history of at least a 30 pack year - Pack year is defined by the number of pack(s) of cigarettes per day times the number of years of smoking - No history of prior lung cancer PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No prior cancer within the past 5 years except basal cell or superficial skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AbrahamChachoua, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000068484; NCI-G01-1913,NYU-9928
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012103
Other Small Cell Lung Cancer Studies:
1. INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
2. A Study of ABT-751 in Patients With Non-Small Cell Lung Cancer
3. GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors
4. ZD6474 and Docetaxel in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
5. Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
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Computed Tomography for Early Detection of Cancer in Women Who Are at Risk for Lung Cancer
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