Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer. (SPORE)
NCT ID: NCT00898209
Last Updated: 2014-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
564 participants
OBSERVATIONAL
2003-04-30
2009-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Health Volunteers
Blood and exhaled breath condensate will be collected.
protein expression analysis
Blood and exhaled breath condensate will be collected.
proteomic profiling
Blood and exhaled breath condensate will be collected.
biologic sample preservation procedure
Blood and exhaled breath condensate will be collected.
laboratory biomarker analysis
Blood and exhaled breath condensate will be collected.
matrix-asst laser desorption/ionization time flight mass spectrometry
Blood and exhaled breath condensate will be collected.
questionnaire administration
Questionnaire will be completed.
Patients at risk or already identified as having lung cancer
Blood and exhaled breath condensate will be collected.
protein expression analysis
Blood and exhaled breath condensate will be collected.
proteomic profiling
Blood and exhaled breath condensate will be collected.
biologic sample preservation procedure
Blood and exhaled breath condensate will be collected.
laboratory biomarker analysis
Blood and exhaled breath condensate will be collected.
matrix-asst laser desorption/ionization time flight mass spectrometry
Blood and exhaled breath condensate will be collected.
questionnaire administration
Questionnaire will be completed.
Interventions
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protein expression analysis
Blood and exhaled breath condensate will be collected.
proteomic profiling
Blood and exhaled breath condensate will be collected.
biologic sample preservation procedure
Blood and exhaled breath condensate will be collected.
laboratory biomarker analysis
Blood and exhaled breath condensate will be collected.
matrix-asst laser desorption/ionization time flight mass spectrometry
Blood and exhaled breath condensate will be collected.
questionnaire administration
Questionnaire will be completed.
Eligibility Criteria
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Inclusion Criteria
* Meets 1 of the following criteria:
* Normal healthy volunteer
* At high risk for lung cancer (e.g., \> 30-pack year history of smoking; chronic obstructive pulmonary disease; or disease-free after surgical resection of lung cancer)
* Diagnosis of stage I, II, IIIA, IIIB, or IV lung cancer
* Must be willing to allow blood and exhaled breath condensate samples to be stored for genetic testing
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Pierre P. Massion, MD
Associate Professor of Medicine (Allergy, Pulmonary & Critical Care) and Cancer Biology; Pulmonary and Critical Care Medicine Doctor
Principal Investigators
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Pierre P. Massion, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Other Identifiers
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VU-VICC-THO-0332
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-030009
Identifier Type: -
Identifier Source: secondary_id
VICC THO 0332
Identifier Type: -
Identifier Source: org_study_id
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