| Protocol Number: |
Version Ao Activation Date: 2/1/04 |
| Trial Phase: |
Specimen/Tissue |
| Maximum # of Subjects: |
1000 |
| IRB Number: |
WIRB IRB#1059456 |
| Study Status: |
Active |
| Enrollment Status: |
Closed |
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| To determine prospectively whetehr the serum proteomic profile can predict the presence of primary NSCLC in patients with suspicious lung lesions who are candidates for lung resection. |
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Eligibility |
Inclusion Criteria: A patient will be eligible for inclusion in this study only if ALL of the following criteria apply: 1. Patient must be > or equal to 18 years of age. 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 teh 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. 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 cacner, the following criteria are met: a. Patient has undergone potentially curative therapy for all prior malignancies, b. 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), c. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies. |
Exclusion Criteria: A patient will NOT be eligible for inclusion in this study is ANY of the following criteria apply: 1. Patient has undergone previous lung resection within the preceding 30 days. 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. |
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