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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:
ClinicalTrials.gov Identifier:
NCT00077324
First Posted: February 12, 2004
Last Update Posted: July 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  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 Procedure: surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Determine whether the serum proteomic profile can predict the presence of primary lung cancer in patients with suspicious lung lesions [ Time Frame: Up to 5 years ]
  • Survival [ Time Frame: Up to 5 years ]

Enrollment: 1000
Study Start Date: February 2004
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgery + blood and serum collection

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.

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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Non-small cell lung cancer patients
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077324


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
John Muir/Mount Diablo Cancer Center - Concord Campus
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, United States, 92357
Sutter Cancer Center at Roseville Medical Center
Roseville, California, United States, 95661
Sutter Cancer Center
Sacramento, California, United States, 95816
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
United States, Connecticut
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, United States, 06810
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
United States, Georgia
Winship Cancer Institute of Emory University
Altanta, Georgia, United States, 30322
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9620
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202-1886
United States, Maryland
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
United States, New Jersey
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States, 08629
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Benedictine Hospital
Kingston, New York, United States, 12401
South Nassau Communities Hospital
Oceanside, New York, United States, 11572
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-8174
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Cancer Treatment Center at Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, United States, 16105
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh, Pennsylvania, United States, 15240
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
U.T. Cancer Institute at University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920-6999
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98114
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: David H. Harpole, MD Duke Cancer Institute
  More Information

Publications:
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.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00077324     History of Changes
Other Study ID Numbers: ACOSOG-Z4031
CDR0000350123 ( Registry Identifier: NCI Physician Data Query )
First Submitted: February 10, 2004
First Posted: February 12, 2004
Last Update Posted: July 6, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I non-small cell lung cancer

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