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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

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
  Purpose

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.


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

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1000
Study Start Date: February 2004
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077324

  Show 73 Study Locations
Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)
Investigators
Study Chair: David H. Harpole, MD Duke Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00077324     History of Changes
Other Study ID Numbers: CDR0000350123, ACOSOG-Z4031
Study First Received: February 10, 2004
Last Updated: July 11, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013