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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
This study is ongoing, but not recruiting participants.
First Received: May 9, 2009   Last Updated: May 16, 2009   History of Changes
Sponsored by: Vanderbilt-Ingram Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00898209
  Purpose

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.


Condition Intervention
Lung Cancer
Genetic: protein expression analysis
Genetic: proteomic profiling
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis
Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
Other: medical chart review
Other: questionnaire administration

Study Type: Observational
Official Title: Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Ability of proteomic patterns in serum and exhaled breath condensate samples to detect and discriminate lung cancer from healthy and from high-risk individuals [ Designated as safety issue: No ]
  • Correlation of proteomic patterns with tumor behavior [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2003
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898209

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000582219, VU-VICC-THO-0332, VU-VICC-030009
Study First Received: May 9, 2009
Last Updated: May 16, 2009
ClinicalTrials.gov Identifier: NCT00898209     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Healthy
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on September 11, 2009