NCT00898209

Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer. (SPORE)

Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 564 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
GENETIC	protein expression analysis	Blood and exhaled breath condensate will be collected.
GENETIC	proteomic profiling	Blood and exhaled breath condensate will be collected.
OTHER	biologic sample preservation procedure	Blood and exhaled breath condensate will be collected.
OTHER	laboratory biomarker analysis	Blood and exhaled breath condensate will be collected.
OTHER	matrix-asst laser desorption/ionization time flight mass spectrometry	Blood and exhaled breath condensate will be collected.
OTHER	questionnaire administration	Questionnaire will be completed.

Timeline

• Start date: 2003-04-01
• Primary completion: 2009-02-01
• Completion: 2009-12-01
• First posted: 2009-05-12
• Last updated: 2014-06-24