Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
NCT ID: NCT00077324
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2004-02-29
2011-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
proteomic profiling
surface-enhanced laser desorption/ionization-time of flight mass spectrometry
biopsy
surgery
Interventions
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proteomic profiling
surface-enhanced laser desorption/ionization-time of flight mass spectrometry
biopsy
surgery
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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David H. Harpole, MD
Role: STUDY_CHAIR
Duke Cancer Institute
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
John Muir/Mount Diablo Cancer Center - Concord Campus
Concord, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, United States
Sutter Cancer Center at Roseville Medical Center
Roseville, California, United States
Sutter Cancer Center
Sacramento, California, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Winship Cancer Institute of Emory University
Altanta, Georgia, United States
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 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
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States
Jewish Hospital
Louisville, Kentucky, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Benedictine Hospital
Kingston, New York, United States
South Nassau Communities Hospital
Oceanside, New York, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Cancer Treatment Center at Good Samaritan Hospital
Cincinnati, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Middletown Regional Hospital
Middletown, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania 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
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
U.T. Cancer Institute at University of Tennessee Medical Center
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
LDS Hospital
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's 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
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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References
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Harpole DH, Meyerson SL. Lung cancer staging: proteomics. Thorac Surg Clin. 2006 Nov;16(4):339-43. doi: 10.1016/j.thorsurg.2006.10.001.
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.
Other Identifiers
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CDR0000350123
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z4031
Identifier Type: -
Identifier Source: org_study_id
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