Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
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|ClinicalTrials.gov Identifier: NCT00077324|
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : July 6, 2016
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 or disease||Intervention/treatment|
|Lung Cancer||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.
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|Official Title:||Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
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
- 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 ]
- Survival [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077324
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|Study Chair:||David H. Harpole, MD||Duke Cancer Institute|