Clinical trial NCT00898209: Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer. (SPORE)
Official title: Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers as well as patients at risk or already identified as having lung cancer.

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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* 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

Primary outcomes:
measure: Ability of proteomic patterns to detect and discriminate lung cancer
timeFrame: Once at study entry
measure: Correlation of proteomic patterns with tumor behavior
timeFrame: Once at study entry
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Pierre P. Massion, MD
role: STUDY_CHAIR
References: