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Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Ability of proteomic patterns to detect and discriminate lung cancer

Outcome Description:

Serum and exhaled breath condensate samples are collected from healthy and high-risk individual with lung cancer

Outcome Time Frame:

Once at study entry

Safety Issue:

No

Principal Investigator

Pierre P. Massion, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC-THO-0332

NCT ID:

NCT00898209

Start Date:

April 2003

Completion Date:

August 2012

Related Keywords:

  • Lung Cancer
  • 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
  • Lung Neoplasms

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