Use Of Proteomic Analysis Of Serum Samples For Detection Of Non-Small Cell Lung Cancer
Data Collection
Collected from today forward - ProspectiveBronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Patient must be ≥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 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. 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 being performed. 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 cancer, the following criteria are met: 1. Patient has undergone potentially curative therapy for all prior malignancies, 2. 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), 3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies. Exclusion Criteria: 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 73 locations
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesSee the locationJohn Muir/Mount Diablo Cancer Center - Concord Campus
Concord, United StatesCity of Hope Comprehensive Cancer Center
Duarte, United StatesGlendale Memorial Hospital Comprehensive Cancer Center
Glendale, United States