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

June 23, 2014 updated by: Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center

Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer

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.

Study Overview

Status

Terminated

Conditions

Lung Cancer

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

564

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers as well as patients at risk or already identified as having lung cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Health Volunteers Blood and exhaled breath condensate will be collected.	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.
Patients at risk or already identified as having lung cancer Blood and exhaled breath condensate will be collected.	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.