Clinical trial NCT00897234: Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers
Official title: Plasma Quantification of Cathepsin D and FAS in Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
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
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have non-small cell lung cancer (NSCLC) will be recruited from the Masonic Cancer Center at the University of Minnesota. Controls will be non-smoking individuals, age matched to the NSCLC subjects recruited through advertising. Normal controls should not be regularly exposed to second hand smoke.

Brief summary: RATIONALE: Studying samples of blood from patients with cancer 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 looking at blood samples from patients with non-small cell lung cancer and from healthy volunteers.

Detailed description: OBJECTIVES:

* Measure plasma cathepsin D levels in patients with non-small cell lung cancer and in healthy volunteers using mass spectometry.
* Measure fatty acid synthase levels in these patients and healthy volunteers using mass spectometry.

OUTLINE: Blood samples are collected from patients and healthy volunteers to measure the levels of cathepsin D and fatty acid synthase by proteomic profiling and mass spectrometry.

Eligibility criteria: Inclusion Criteria:

Non-Small Cell Lung Cancer Patients

* Documented diagnosis of non-small cell lung cancer, any stage and any time point in the course of treatment (i.e., at diagnosis, during any treatment, and during post treatment surveillance)
* Measurable disease by CT scan within the past 4 weeks

Healthy volunteer

* Non-smoking, defined as \< 5 packs/year history of smoking and cessation of smoking ≥ 6 months ago OR a never smoker

  * Not regularly exposed (i.e., daily) to second-hand smoke

Exclusion Criteria:

* Severe underlying lung disease (i.e., chronic obstructive pulmonary disease with FEV_1 \< 1.0 L, pulmonary fibrosis, bronchiectasis, cystic fibrosis, etc.) as determined by enrolling researcher.

Written consent must be given for both subjects and controls.

Primary outcomes:
measure: Levels of cathepsin D
timeFrame: At Routine Follow-Up
Secondary outcomes:
measure: Levels of fatty acid synthase (FAS)
timeFrame: At Routine Follow-Up
measure: Global microRNA expression
timeFrame: At Routine Follow-Up
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Robert A. Kratzke, MD
role: PRINCIPAL_INVESTIGATOR
References: