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Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy 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 Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy Clinical research trials and Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy 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 Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy. Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy 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 Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy clinical trial. Participants typically obtain the most effective healthcare available for their Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy 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 > "P" Clinical Trials Conditions > Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy  Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy
Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy
For Condition: Carcinoma, Non-Small-Cell Lung,Carcinoma, Small Cell,Carcinoma, Squamous Cell,Lung Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: If possible, patients produce a 3-day pooled sputum sample prior to bronchoscopy. Patients then undergo tracheobronchial white-light bronchoscopy followed by autofluorescence bronchoscopy using the Lung Imaging Fluorescence Endoscopic (LIFE) Device attached to a computerized video camera. Visualized tissue is classified as either normal, abnormal, or suspicious. Abnormal or suspicious tissue is biopsied, as is tissue from 1 or 2 randomly chosen normal sites. Immunohistochemical analysis of the biopsy material is conducted without knowledge of the bronchoscopic results. Patients unable to produce a sputum sample prior to bronchoscopy are required to do so after bronchoscopy.
Details: Patients at risk for lung cancer will undergo fiberoptic bronchoscopy with white light and fluorescent bronchoscopy. Patients will have areas in their airways classified as normal (Class I), abnormal (Class II), and suspicious for malignancy (Class III) using white light and followed by an examination with fluorescent light bronchoscopy with the same classification. The class III lesions will be biopsied and at least one biopsy will be done of Class II lesions. The study will assess the impact of fluorescent light bronchoscopy as an adjunct to white light bronchoscopy on the rate of detection and characterization of lesions in patients at risk for lung cancer. The number of preneoplastic lesions in patients treated with combined modality therapy will be compared to the number of lesions identified in patients with surgically resected non-small cell lung cancer. The patient's sputum and biopsy specimens will be studied for the presence of a 31 kilodalton protein detected with the monoclonal antibody, 703D4. The presence of this epitope in the sputum of patients at high risk for lung cancer has been associated with the subsequent development of clinically evident lung cancer. Patients will be studied to determine the relationship between the reactivity of 703D4 in the cells from their tumors, airways, and sputum.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients must be able to sign informed consent forms. Patients must be capable of producing sputum samples. Patients must be 18 years of age or older. Patients who have an ECOG performance status of 0-2 are eligible. Patients with any of the following: A) Patients with known or suspected brochogenic carcinomas who are scheduled for bronchoscopy as part of a standard diagnostic or staging workup. B) Patients with Stage I or II completely resected non-smal cell lung cancer with no evidence of metastatic disease. C) Patients with stageIII non-small cell lung cancer alive and free of cancer for 2 or more years. D) Patients with small cell lung cancer alive and free of cancer for 2 or mor years. E) Patients with completely resected head or neck cancer without evidence of metastatic disease. Patients must be excluded from the clinical trial if they fall into one of the following categories: Patients with uncontrolled hypertension (systolic pressure>200mm Hg, Diastolic pressure>120mm Hg. Patients with unstable angina. Patients with white count less than 2000 or greater than 20,000. Patients with platelet count less than 50,000. Patients with known bleeding disorder. Patients with know reaction to topical xylocaine. Patients who have had fluorescent photosensitizing drugs, such as Photofrin, within 3 months of the LIFE examination. Patients who have received ionizing radiation treatment to the chest within 18 months of the LIFE examination. Patients who have had YAG laser treatment in the lung within 1 month of the LIFE examination. Patients who are pregnant.
Total Enrollment: 70
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960128; 96-C-0128
Study Start Date: August 27, 1996
Record last reviewed: July 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001511
Other Carcinoma, Squamous Cell Studies:
1. Study to Compare the Overall Survival of Patients Receiving INGN 201 (study drug) with Patients Receiving Methotrexate
2. Trial of Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer in Previously Treated Patients
3. Study Of Zd1839 (Iressa™) Versus Methotrexate For Previously Treated Patients With Squamous Cell Carcinoma Of The Head And Neck
4. Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy
5. An Open-Label Phase 2 Study of Lonafarnib in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck
Related Studies:
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Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy
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