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
  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-asst laser desorption/ionization time flight mass spectrometry
Other: questionnaire administration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Peripheral blood lymphocyte DNA, and Exhaled breath condensate


Enrollment: 564
Study Start Date: April 2003
Study Completion Date: December 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Health Volunteers
Blood and exhaled breath condensate will be collected.
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
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.
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

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
Sampling Method:   Non-Probability Sample
Study Population

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Pierre P. Massion, MD, Associate Professor of Medicine (Allergy, Pulmonary & Critical Care) and Cancer Biology; Pulmonary and Critical Care Medicine Doctor, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00898209     History of Changes
Other Study ID Numbers: VICC THO 0332, VU-VICC-THO-0332, VU-VICC-030009
Study First Received: May 9, 2009
Last Updated: June 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
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

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

ClinicalTrials.gov processed this record on October 23, 2014