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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00898209
Enrollment
564
Registered
2009-05-12
Start date
2003-04-30
Completion date
2009-12-31
Last updated
2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

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

Brief summary

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.

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.

Interventions

GENETICprotein expression analysis

Blood and exhaled breath condensate will be collected.

GENETICproteomic profiling

Blood and exhaled breath condensate will be collected.

OTHERbiologic sample preservation procedure

Blood and exhaled breath condensate will be collected.

OTHERlaboratory biomarker analysis

Blood and exhaled breath condensate will be collected.

OTHERmatrix-asst laser desorption/ionization time flight mass spectrometry

Blood and exhaled breath condensate will be collected.

OTHERquestionnaire administration

Questionnaire will be completed.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ability of proteomic patterns to detect and discriminate lung cancerOnce at study entrySerum and exhaled breath condensate samples are collected from healthy and high-risk individual with lung cancer
Correlation of proteomic patterns with tumor behaviorOnce at study entry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026