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

This study has been terminated.
(This study competed with another VICC study)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00898209
First received: May 9, 2009
Last updated: June 23, 2014
Last verified: April 2013

May 9, 2009
June 23, 2014
April 2003
February 2009   (final data collection date for primary outcome measure)
  • Ability of proteomic patterns to detect and discriminate lung cancer [ Time Frame: Once at study entry ] [ Designated as safety issue: No ]
    Serum and exhaled breath condensate samples are collected from healthy and high-risk individual with lung cancer
  • Correlation of proteomic patterns with tumor behavior [ Time Frame: Once at study entry ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00898209 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer. (SPORE)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Peripheral blood lymphocyte DNA, and Exhaled breath condensate

Non-Probability Sample

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

Lung Cancer
  • Genetic: protein expression analysis
    Blood and exhaled breath condensate will be collected.
    Other Name: protein expression analysis
  • Genetic: proteomic profiling
    Blood and exhaled breath condensate will be collected.
    Other Name: proteomic profiling
  • Other: biologic sample preservation procedure
    Blood and exhaled breath condensate will be collected.
    Other Name: biologic sample preservation procedure
  • Other: laboratory biomarker analysis
    Blood and exhaled breath condensate will be collected.
    Other Name: laboratory biomarker analysis
  • Other: matrix-asst laser desorption/ionization time flight mass spectrometry
    Blood and exhaled breath condensate will be collected.
    Other Name: matrix-asst laser desorption/ionization time flight mass spectrometry
  • Other: questionnaire administration
    Questionnaire will be completed.
    Other Name: questionnaire administration
  • Health Volunteers
    Blood and exhaled breath condensate will be collected.
    Interventions:
    • Genetic: protein expression analysis
    • Genetic: proteomic profiling
    • Other: biologic sample preservation procedure
    • Other: laboratory biomarker analysis
    • Other: matrix-asst laser desorption/ionization time flight mass spectrometry
    • Other: questionnaire administration
  • Patients at risk or already identified as having lung cancer
    Blood and exhaled breath condensate will be collected.
    Interventions:
    • Genetic: protein expression analysis
    • Genetic: proteomic profiling
    • Other: biologic sample preservation procedure
    • Other: laboratory biomarker analysis
    • Other: matrix-asst laser desorption/ionization time flight mass spectrometry
    • Other: questionnaire administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
564
December 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00898209
VICC THO 0332, VU-VICC-THO-0332, VU-VICC-030009
Yes
Pierre P. Massion, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Pierre P. Massion, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP