Status:
COMPLETED
Proteomic Profiling in Diagnosing Non-Small Cell Lung Cancer in Patients Who Are Undergoing Lung Resection for Suspicious Stage I Lung Lesions
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
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 ...
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 l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00077324
Start Date
February 1 2004
End Date
November 1 2011
Last Update
July 6 2016
Active Locations (73)
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1
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
John Muir/Mount Diablo Cancer Center - Concord Campus
Concord, California, United States, 94524-4110
3
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
4
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204