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

Terminated

• Conditions: Lung Cancer
• Interventions: Genetic: protein expression analysis; Genetic: proteomic profiling; Other: biologic sample preservation procedure; Other: laboratory biomarker analysis; Other: matrix-asst laser desorption/ionization time flight mass spectrometry; Other: questionnaire administration

• Registration Number: NCT00898209
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief 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.

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2009-02
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Study Completion: 2009-12
• Status Verified: 2013-04
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 564

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health Volunteers	protein expression analysis	Blood and exhaled breath condensate will be collected.
Health Volunteers	proteomic profiling	Blood and exhaled breath condensate will be collected.
Patients at risk or already identified as having lung cancer	protein expression analysis	Blood and exhaled breath condensate will be collected.
Health Volunteers	laboratory biomarker analysis	Blood and exhaled breath condensate will be collected.
Patients at risk or already identified as having lung cancer	biologic sample preservation procedure	Blood and exhaled breath condensate will be collected.
Health Volunteers	matrix-asst laser desorption/ionization time flight mass spectrometry	Blood and exhaled breath condensate will be collected.
Patients at risk or already identified as having lung cancer	proteomic profiling	Blood and exhaled breath condensate will be collected.
Patients at risk or already identified as having lung cancer	laboratory biomarker analysis	Blood and exhaled breath condensate will be collected.
Patients at risk or already identified as having lung cancer	matrix-asst laser desorption/ionization time flight mass spectrometry	Blood and exhaled breath condensate will be collected.
Health Volunteers	biologic sample preservation procedure	Blood and exhaled breath condensate will be collected.
Health Volunteers	questionnaire administration	Blood and exhaled breath condensate will be collected.
Patients at risk or already identified as having lung cancer	questionnaire administration	Blood and exhaled breath condensate will be collected.

Primary Outcome Measures

Name	Time	Method
Ability of proteomic patterns to detect and discriminate lung cancer	Once at study entry	Serum and exhaled breath condensate samples are collected from healthy and high-risk individual with lung cancer
Correlation of proteomic patterns with tumor behavior	Once at study entry