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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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedDiagnosticCompleted18 and overNCI, OtherCDR0000350123
ACOSOG-Z4031, NCT00077324

Trial Description


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.

Further Study Information



  • 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.

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.

Eligibility Criteria


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



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • Not specified


  • No prior radiotherapy


  • More than 30 days since other prior lung resection


  • More than 60 days since prior blood product transfusion

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Surgeons

  • National Cancer Institute
David H. Harpole, Study Chair

Link to the current record.
NLM Identifier NCT00077324 processed this data on April 09, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to