Lung Cancer Clinical Trial
Official title:
Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer
RATIONALE: Collecting and storing samples of blood and exhaled breath from patients with
cancer and from healthy participants to study in the laboratory may help doctors learn more
about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is collecting and analyzing samples of blood and exhaled breath
from patients who have or are at high risk for lung cancer and from healthy participants.
OBJECTIVES:
- To evaluate the ability of proteomic patterns in serum and exhaled breath condensate
samples to detect and discriminate lung cancer from healthy and from high-risk
individuals.
- To correlate proteomic patterns with tumor behavior.
OUTLINE: This is a multicenter study.
Blood and exhaled breath condensate samples are collected, whenever possible, at a time
medically indicated for other purposes (e.g., work-up, pre-op, surgical procedures). The
samples are used to produce genetic material (i.e., DNA, RNA) and molecular material (i.e.,
proteins) that will be stored for future studies, including studies that may not be related
to lung cancer. Future genetic studies related to lung cancer may include studies of protein
expression patterns via matrix-assisted laser desorption/ionization time of flight mass
spectrometry that may serve as predictive molecular markers of lung cancer.
Participants complete a 15-minute Lung Spore Database questionnaire at the time of study
enrollment to provide information on demographics (e.g., date of birth, address, phone
number), medical and smoking history, personal and family history of cancer and cancer
treatment, and current medications. Medical records are reviewed at the time of study
enrollment and then over approximately 5 years to obtain information, including test
results, associated with the diagnosis of cancer. Participants may also be contacted by
phone at a later time to answer questions about their health status.
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Observational Model: Cohort, Time Perspective: Prospective
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