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Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
This study is ongoing, but not recruiting participants.
Study NCT00077324   Information provided by National Cancer Institute (NCI)
First Received: February 10, 2004   Last Updated: February 6, 2009   History of Changes

February 10, 2004
February 6, 2009
February 2004
 
 
 
Complete list of historical versions of study NCT00077324 on ClinicalTrials.gov Archive Site
 
 
 
Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer

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.

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Tertiary

  • Determine whether novel molecular strategies can predict the presence of lung cancer and/or the biologic behavior of an individual cancer in these patients.

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.

 
Interventional
Diagnostic
Lung Cancer
  • Genetic: proteomic profiling
  • Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
  • Procedure: biopsy
 
Harpole DH, Meyerson SL. Lung cancer staging: proteomics. Thorac Surg Clin. 2006 Nov;16(4):339-43. Review.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
1000
 
 

DISEASE CHARACTERISTICS:

  • Clinically suspicious stage I (T1-2, N0, M0) lung lesion
  • No metastatic disease in the liver or adrenal glands by helical CT scan

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer, surgically treated carcinoma in situ of the cervix, or surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast AND at low risk for recurrence

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • More than 30 days since other prior lung resection

Other

  • More than 60 days since prior blood product transfusion
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00077324
 
CDR0000350123, ACOSOG-Z4031
American College of Surgeons
National Cancer Institute (NCI)
Study Chair: David H. Harpole, MD Duke University
National Cancer Institute (NCI)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP