Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
- Conditions
- Lung Cancer
- Interventions
- Genetic: proteomic profilingOther: surface-enhanced laser desorption/ionization-time of flight mass spectrometryProcedure: biopsyProcedure: surgery
- Registration Number
- NCT00077324
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
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Patient must be ≥18 years of age.
-
Patient must have a clinically suspicious stage I (cT1-2 N0 M0) lung lesion.
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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.
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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.
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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.
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If patient is a survivor of a prior cancer, the following criteria are met:
- Patient has undergone potentially curative therapy for all prior malignancies,
- 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),
- Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
- Patient has undergone previous lung resection within the preceding 30 days.
- Patient has received prior chemotherapy or radiotherapy.
- Patient has had a blood product transfusion of any kind within the past 60 days of the operative procedure.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Surgery + blood and serum collection surface-enhanced laser desorption/ionization-time of flight mass spectrometry 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. Surgery + blood and serum collection proteomic profiling 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. Surgery + blood and serum collection surgery 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. Surgery + blood and serum collection biopsy 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.
- Primary Outcome Measures
Name Time Method Determine whether the serum proteomic profile can predict the presence of primary lung cancer in patients with suspicious lung lesions Up to 5 years Survival Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (73)
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Cancer Treatment Center at Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
John Muir/Mount Diablo Cancer Center - Concord Campus
🇺🇸Concord, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
George Washington University Medical Center
🇺🇸Washington, District of Columbia, United States
John Muir/Mt. Diablo Comprehensive Cancer Center
🇺🇸Walnut Creek, California, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
MBCCOP-Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Greater Baltimore Medical Center Cancer Center
🇺🇸Baltimore, Maryland, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Stony Brook University Cancer Center
🇺🇸Stony Brook, New York, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Glendale Memorial Hospital Comprehensive Cancer Center
🇺🇸Glendale, California, United States
Veterans Affairs Medical Center - Loma Linda (Pettis)
🇺🇸Loma Linda, California, United States
Praxair Cancer Center at Danbury Hospital
🇺🇸Danbury, Connecticut, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Winship Cancer Institute of Emory University
🇺🇸Altanta, Georgia, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, 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
Veterans Affairs Medical Center - Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Fox Chase Cancer Center at St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
South Nassau Communities Hospital
🇺🇸Oceanside, New York, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St Louis, Missouri, United States
Benedictine Hospital
🇺🇸Kingston, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Jameson Memorial Hospital - North Campus
🇺🇸New Castle, Pennsylvania, United States
AnMed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
Rhode Island Hospital Comprehensive Cancer Center
🇺🇸Providence, Rhode Island, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
U.T. Cancer Institute at University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, 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
Sutter Cancer Center at Roseville Medical Center
🇺🇸Roseville, California, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States