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

Vanderbilt University Medical Center

Status: Terminated

Conditions: Lung Cancer

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00898209

VICC THO 0332

VU-VICC-THO-0332

VU-VICC-030009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 564 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

564 participants in 2 patient groups

Health Volunteers

Description:

Blood and exhaled breath condensate will be collected.

Treatment:

Other: questionnaire administration

Other: biologic sample preservation procedure

Genetic: protein expression analysis

Other: laboratory biomarker analysis

Genetic: proteomic profiling

Other: matrix-asst laser desorption/ionization time flight mass spectrometry

Patients at risk or already identified as having lung cancer

Description:

Blood and exhaled breath condensate will be collected.

Treatment:

Other: questionnaire administration

Other: biologic sample preservation procedure

Genetic: protein expression analysis

Other: laboratory biomarker analysis

Genetic: proteomic profiling

Other: matrix-asst laser desorption/ionization time flight mass spectrometry