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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



Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who are Undergoing Lung Resection for Suspicious Stage I Lung Lesions

For Condition: stage 1 non-small cell lung cancer
Status: Recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: 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: Clinical trial to study the effectiveness of proteomic profiling in diagnosing non-small cell lung cancer in patients who are undergoing resection for suspicious (abnormal) stage I lung lesions.
Details: 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.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DavidHarpole,  Study Chair,  Duke Comprehensive Cancer Center

Duke Comprehensive Cancer Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting David  Harpole 919-668-8400

Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati,  Ohio,  45220-2288
United States
Recruiting John  Howington 513-861-3100, ext. 6471


Additional Information:
Study ID Numbers:
  CDR0000350123;  ACOSOG-Z4031
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077324

Other Stage 1 Non-Small Cell Lung Cancer Studies:
1. Video-Assisted Surgery Followed by Radiation Therapy in Treating Patients With Stage I Non-small Cell Lung Cancer and Poor Heart and Lung Function

2. Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery

3. Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer

4. Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

5. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer

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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

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