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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077324
• Other study ID #: ACOSOG-Z4031
• Secondary ID: CDR0000350123
• Status: Completed
• Phase: N/A
• First received: February 10, 2004
• Last updated: July 1, 2016
• Start date: February 2004
• Est. completion date: November 2011

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must be =18 years of age.

2. Patient must have a clinically suspicious stage I (cT1-2 N0 M0) lung lesion.

3. Patient must have pre-operative imaging procedures within 60 days prior to the date of the lung resection: Helical CT scan of the chest and CT scan of the upper abdomen, including the liver and adrenal glands (with or without IV contrast), as clinically indicated. The helical CT must rule out metastatic disease in the liver and adrenal glands.

4. Patient, or the patient's legally acceptable representative, must provide a signed and dated written informed consent PRIOR to registration and any study-related procedures being performed.

5. Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient PRIOR to registration and any study-related procedures being performed.

6. If patient is a survivor of a prior cancer, the following criteria are met:

1. Patient has undergone potentially curative therapy for all prior malignancies,

2. No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),

3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Exclusion Criteria:

1. Patient has undergone previous lung resection within the preceding 30 days.

2. Patient has received prior chemotherapy or radiotherapy.

3. Patient has had a blood product transfusion of any kind within the past 60 days of the operative procedure.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• proteomic profiling

Other:
• surface-enhanced laser desorption/ionization-time of flight mass spectrometry

Procedure:
• biopsy

• surgery

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Winship Cancer Institute of Emory University	Altanta	Georgia
United States	AnMed Health Cancer Center	Anderson	South Carolina
United States	MBCCOP-Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Greater Baltimore Medical Center Cancer Center	Baltimore	Maryland
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Cancer Treatment Center at Good Samaritan Hospital	Cincinnati	Ohio
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	John Muir/Mount Diablo Cancer Center - Concord Campus	Concord	California
United States	Praxair Cancer Center at Danbury Hospital	Danbury	Connecticut
United States	CCOP - Dayton	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	California
United States	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Benedictine Hospital	Kingston	New York
United States	U.T. Cancer Institute at University of Tennessee Medical Center	Knoxville	Tennessee
United States	Veterans Affairs Medical Center - Loma Linda (Pettis)	Loma Linda	California
United States	Jewish Hospital	Louisville	Kentucky
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	West Virginia
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Jameson Memorial Hospital - North Campus	New Castle	Pennsylvania
United States	South Nassau Communities Hospital	Oceanside	New York
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Veterans Affairs Medical Center - Pittsburgh	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Miriam Hospital	Providence	Rhode Island
United States	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island
United States	Reid Hospital & Health Care Services, Incorporated	Richmond	Indiana
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Sutter Cancer Center at Roseville Medical Center	Roseville	California
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Sutter Cancer Center	Sacramento	California
United States	LDS Hospital	Salt Lake City	Utah
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Institute at St. John's Hospital	Springfield	Illinois
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri
United States	Stony Brook University Cancer Center	Stony Brook	New York
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Fox Chase Cancer Center at St. Francis Medical Center	Trenton	New Jersey
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	John Muir/Mt. Diablo Comprehensive Cancer Center	Walnut Creek	California
United States	George Washington University Medical Center	Washington	District of Columbia
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Grogan EL, Deppen SA, Ballman KV, et al.: Accuracy of FDG-PET to diagnose lung cancer in the ACOSOG Z4031 trial. [Abstract] J Clin Oncol 30 (Suppl 15): A-7008, 2012.

Harpole D, Ballman KV, Oberg AL, et al.: Proteomic analysis for detection of NSCLC: results of ACOSOG Z4031. [Abstract] J Clin Oncol 29 (Suppl 15): A-7003, 2011.

Harpole DH, Meyerson SL. Lung cancer staging: proteomics. Thorac Surg Clin. 2006 Nov;16(4):339-43. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether the serum proteomic profile can predict the presence of primary lung cancer in patients with suspicious lung lesions		Up to 5 years	No
Primary	Survival		Up to 5 years	No