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Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer

18 Years
Not Enrolling
Lung Cancer

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Trial Information

Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer



- 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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

David H. Harpole, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:




Start Date:

February 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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