Lung Cancer Clinical Trial
Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
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.
Full 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 Criteria
Inclusion Criteria:
Patient must be ≥18 years of age.
Patient must have a clinically suspicious stage I (cT1-2 N0 M0) lung lesion.
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.
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.
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.
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.
Exclusion Criteria:
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.
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There are 70 Locations for this study
Birmingham Alabama, 35294, United States
Concord California, 94524, United States
Duarte California, 91010, United States
Glendale California, 91204, United States
Loma Linda California, 92357, United States
Roseville California, 95661, United States
Sacramento California, 95816, United States
Walnut Creek California, 94598, United States
Danbury Connecticut, 06810, United States
Washington District of Columbia, 20037, United States
Fort Lauderdale Florida, 33308, United States
Altanta Georgia, 30322, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60611, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62781, United States
Springfield Illinois, 62794, United States
Beech Grove Indiana, 46107, United States
Richmond Indiana, 47374, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21204, United States
Boston Massachusetts, 02114, United States
Royal Oak Michigan, 48073, United States
Minneapolis Minnesota, 55417, United States
Rochester Minnesota, 55905, United States
St Louis Missouri, 63110, United States
Trenton New Jersey, 08629, United States
Buffalo New York, 14263, United States
Kingston New York, 12401, United States
Oceanside New York, 11572, United States
Stony Brook New York, 11794, United States
Syracuse New York, 13210, United States
Durham North Carolina, 27710, United States
Rutherfordton North Carolina, 28139, United States
Grand Forks North Dakota, 58201, United States
Akron Ohio, 44307, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45242, United States
Cincinnati Ohio, 45267, United States
Dayton Ohio, 45405, United States
Dayton Ohio, 45406, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Kettering Ohio, 45429, United States
Middletown Ohio, 45044, United States
Troy Ohio, 45373, United States
Xenia Ohio, 45385, United States
Abington Pennsylvania, 19001, United States
New Castle Pennsylvania, 16105, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15232, United States
Pittsburgh Pennsylvania, 15240, United States
Wynnewood Pennsylvania, 19096, United States
Providence Rhode Island, 02903, United States
Providence Rhode Island, 02906, United States
Anderson South Carolina, 29621, United States
Charleston South Carolina, 29425, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Knoxville Tennessee, 37920, United States
Nashville Tennessee, 37232, United States
Salt Lake City Utah, 84143, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98114, United States
Morgantown West Virginia, 26506, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
Toronto Ontario, M5G 2, Canada
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