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| Sponsor: | American College of Surgeons |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077324 |
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 |
| Study Type: | Interventional |
| Study Design: | Diagnostic |
| Official Title: | Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2004 |
OBJECTIVES:
Primary
Secondary
Tertiary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Glendale Memorial Hospital Comprehensive Cancer Center | |
| Glendale, California, United States, 91204 | |
| John Muir/Mount Diablo Cancer Center - Concord Campus | |
| Concord, California, United States, 94524-4110 | |
| John Muir/Mt. Diablo Comprehensive Cancer Center | |
| Walnut Creek, California, United States, 94598 | |
| Sutter Cancer Center at Roseville Medical Center | |
| Roseville, California, United States, 95661 | |
| Sutter Cancer Center | |
| Sacramento, California, United States, 95816 | |
| Veterans Affairs Medical Center - Loma Linda (Pettis) | |
| Loma Linda, California, United States, 92357 | |
| 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 | |
| MBCCOP-Medical College of Georgia Cancer Center | |
| Augusta, Georgia, United States, 30912 | |
| Winship Cancer Institute of Emory University | |
| Altanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Cancer Institute at St. John's Hospital | |
| Springfield, Illinois, United States, 62702 | |
| Regional Cancer Center at Memorial Medical Center | |
| Springfield, Illinois, United States, 62781 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794-9620 | |
| United States, Indiana | |
| Reid Hospital & Health Care Services, Incorporated | |
| Richmond, Indiana, United States, 47374 | |
| St. Francis Hospital and Health Centers - Beech Grove Campus | |
| Beech Grove, Indiana, United States, 46107 | |
| 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 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| 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 | |
| Benedictine Hospital | |
| Kingston, New York, United States, 12401 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| 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 | |
| Bethesda North Hospital | |
| Cincinnati, Ohio, United States, 45242 | |
| Cancer Treatment Center at Good Samaritan Hospital | |
| Cincinnati, Ohio, United States, 45220 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| McDowell Cancer Center at Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| United States, Pennsylvania | |
| Allegheny Cancer Center at Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| 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 | |
| Rosenfeld Cancer Center at Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Jameson Memorial Hospital - North Campus | |
| New Castle, Pennsylvania, United States, 16105 | |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224-1791 | |
| United States, Rhode Island | |
| Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| Rhode Island Hospital Comprehensive Cancer Center | |
| Providence, Rhode Island, United States, 02903 | |
| United States, South Carolina | |
| AnMed Health Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| 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. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| 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 | |
| Study Chair: | David H. Harpole, MD | Duke University |
More Information
| Study ID Numbers: | CDR0000350123, ACOSOG-Z4031 |
| Study First Received: | February 10, 2004 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00077324 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
