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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00077324

First received: February 10, 2004

Last updated: July 11, 2012

Last verified: April 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

February 10, 2004

Last Updated Date

July 11, 2012

Start Date ^ICMJE

February 2004

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00077324 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Primary Purpose: Diagnostic

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Genetic: proteomic profiling
Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
Procedure: biopsy

Study Arm (s)

Not Provided

Publications *

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 ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1000

Completion Date

Not Provided

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00077324

Other Study ID Numbers ^ICMJE

CDR0000350123, ACOSOG-Z4031

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

American College of Surgeons

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

David H. Harpole, MD

Duke Cancer Institute

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2006

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

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