Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Closed	18 and over	NCI	ACOSOG-Z4031 NCT00077324

Objectives

Primary

1. 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

1. Correlate the serum proteomic profile with pathologic nodal status and histopathologic features of primary lung cancer in these patients.
2. Correlate the initial and follow-up serum proteomic profile with overall and cancer-specific survival of these patients.
3. Correlate changes in the proteomic profile (preoperative to postoperative) with overall and cancer-specific survival of these patients.

Tertiary

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

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

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

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

Expected Enrollment

A total of 1,000 patients will be accrued for this study within 2 years.

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.

Harpole DH, Meyerson SL: Lung cancer staging: proteomics. Thorac Surg Clin 16 (4): 339-43, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

David Harpole, MD, Protocol chair		Ph: 919-668-8413

Registry Information
Official Title		Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer
Trial Start Date		2004-02-01
Registered in ClinicalTrials.gov		NCT00077324
Date Submitted to PDQ		2003-12-17
Information Last Verified		2006-04-29
NCI Grant/Contract Number		CA76001

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