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

18 Years
Not Enrolling
Lung Cancer

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Trial Information

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



- 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.


- 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.


- 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.

Inclusion Criteria


- Clinically suspicious stage I (T1-2, N0, M0) lung lesion

- No metastatic disease in the liver or adrenal glands by helical CT scan



- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy

- Not specified


- No prior chemotherapy

Endocrine therapy

- Not specified


- No prior radiotherapy


- More than 30 days since other prior lung resection


- More than 60 days since prior blood product transfusion

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

David H. Harpole, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:




Start Date:

February 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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Duke Comprehensive Cancer Center Durham, North Carolina  27710
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
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University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
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CCOP - Dayton Kettering, Ohio  45429
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Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Sutter Cancer Center Sacramento, California  95816
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
City of Hope Comprehensive Cancer Center Duarte, California  91010
Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Rhode Island Hospital Comprehensive Cancer Center Providence, Rhode Island  02903
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Veterans Affairs Medical Center - Loma Linda (Pettis) Loma Linda, California  92357
MBCCOP-Medical College of Georgia Cancer Center Augusta, Georgia  30912-4000
University of Virginia Cancer Center Charlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Sutter Cancer Center at Roseville Medical Center Roseville, California  95661
John Muir/Mt. Diablo Comprehensive Cancer Center Walnut Creek, California  94598
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Reid Hospital & Health Care Services, Incorporated Richmond, Indiana  47374
Fox Chase Cancer Center at St. Francis Medical Center Trenton, New Jersey  08629
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
Good Samaritan Hospital Dayton, Ohio  45406
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Green Bay Oncology, Limited at St. Vincent Hospital Green Bay, Wisconsin  54301-3526
Altru Cancer Center at Altru Hospital Grand Forks, North Dakota  58201
Allegheny Cancer Center at Allegheny General Hospital Pittsburgh, Pennsylvania  15212
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224-1791
Praxair Cancer Center at Danbury Hospital Danbury, Connecticut  06810
Greater Baltimore Medical Center Cancer Center Baltimore, Maryland  21204
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Jewish Hospital Louisville, Kentucky  40202-1886
Benedictine Hospital Kingston, New York  12401
Rutherford Hospital Rutherfordton, North Carolina  28139
Bethesda North Hospital Cincinnati, Ohio  45242
Cancer Treatment Center at Good Samaritan Hospital Cincinnati, Ohio  45220
AnMed Health Cancer Center Anderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Miriam Hospital Providence, Rhode Island  02906
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
Glendale Memorial Hospital Comprehensive Cancer Center Glendale, California  91204
U.T. Cancer Institute at University of Tennessee Medical Center Knoxville, Tennessee  37920-2911
South Nassau Communities Hospital Oceanside, New York  11572
Jameson Memorial Hospital - North Campus New Castle, Pennsylvania  16105
John Muir/Mount Diablo Cancer Center - Concord Campus Concord, California  94524-4110