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Sponsored by: |
Vanderbilt-Ingram Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00898209 |
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 |
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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 |
Estimated Enrollment: | 1000 |
Study Start Date: | April 2003 |
Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
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 |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Healthy Carcinoma, Non-Small-Cell Lung |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases |