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Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077324 |
RATIONALE: Evaluating specific proteins in the blood may be an effective and noninvasive procedure to help doctors determine if a patient has early non-small cell lung cancer.
PURPOSE: This clinical trial is studying proteomic profiling to see how well it works in diagnosing non-small cell lung cancer in patients who are undergoing resection for suspicious (abnormal) stage I lung lesions.
Condition | Intervention |
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Lung Cancer |
Genetic: proteomic profiling Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry Procedure: biopsy |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer |
Estimated Enrollment: | 1000 |
Study Start Date: | February 2004 |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: Patients undergo lung resection. Patients also undergo preoperative and postoperative collection of whole blood and serum for proteomic profiling using surface-enhanced laser desorption/ionization-time of flight mass spectrometry. A lung tissue biopsy taken at surgery is also analyzed.
Patients are followed at 60-90 days and then annually for 2-5 years.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | David H. Harpole, MD | Duke University |
Study ID Numbers: | CDR0000350123, ACOSOG-Z4031 |
Study First Received: | February 10, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00077324 History of Changes |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |