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

Lung Cancer Clinical Trial

Official title:

Serum and Exhaled Breath Condensate MALDI-MS of Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00898209
• Other study ID #: VICC THO 0332
• Secondary ID: VU-VICC-THO-0332
• Status: Terminated
• Phase: N/A
• First received: May 9, 2009
• Last updated: June 23, 2014
• Start date: April 2003
• Est. completion date: December 2009

Study information

• Verified date: April 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 564
• Est. completion date: December 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• protein expression analysis
Blood and exhaled breath condensate will be collected.
• proteomic profiling
Blood and exhaled breath condensate will be collected.

Other:
• biologic sample preservation procedure
Blood and exhaled breath condensate will be collected.
• laboratory biomarker analysis
Blood and exhaled breath condensate will be collected.
• matrix-asst laser desorption/ionization time flight mass spectrometry
Blood and exhaled breath condensate will be collected.
• questionnaire administration
Questionnaire will be completed.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of proteomic patterns to detect and discriminate lung cancer	Serum and exhaled breath condensate samples are collected from healthy and high-risk individual with lung cancer	Once at study entry	No
Primary	Correlation of proteomic patterns with tumor behavior		Once at study entry	No