Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
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.
Genetic: proteomic profiling
Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer|
- Determine whether the serum proteomic profile can predict the presence of primary lung cancer in patients with suspicious lung lesions [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Surgery + blood and serum collection
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.
|Genetic: proteomic profiling Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry Procedure: biopsy Procedure: surgery|
- Determine, prospectively, whether serum proteomic profiling can predict the presence of primary non-small cell lung cancer in patients with clinically suspicious stage I lung lesions who are undergoing lung resection.
- Correlate the serum proteomic profile with pathologic nodal status and histopathologic features of primary lung cancer in these patients.
- Correlate the initial and follow-up serum proteomic profile with overall and cancer-specific survival of these patients.
- Correlate changes in the proteomic profile (preoperative to postoperative) with overall and cancer-specific survival of these patients.
- Determine whether novel molecular strategies can predict the presence of lung cancer and/or the biologic behavior of an individual cancer in these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077324
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|Study Chair:||David H. Harpole, MD||Duke Cancer Institute|