Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00897234
First received: May 9, 2009
Last updated: November 22, 2010
Last verified: November 2010

May 9, 2009
November 22, 2010
December 2008
August 2010   (final data collection date for primary outcome measure)
Levels of cathepsin D [ Time Frame: At Routine Follow-Up ] [ Designated as safety issue: No ]
Measure plasma CD levels in patients with non-small cell lung cancer and non-smoker healthy controls using mass spectrometry.
Levels of cathepsin D [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897234 on ClinicalTrials.gov Archive Site
  • Levels of fatty acid synthase (FAS) [ Time Frame: At Routine Follow-Up ] [ Designated as safety issue: No ]
    Measure FAS levels in patients with non-small cell lung cancer and non-smoker healthy controls using mass spectrometry.
  • Global microRNA expression [ Time Frame: At Routine Follow-Up ] [ Designated as safety issue: No ]
    Measure global microRNA expression by microarray analysis using Illumina probes.
Levels of fatty acid synthase [ Designated as safety issue: No ]
 
 
 
Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers
Plasma Quantification of Cathepsin D and FAS in Non-Small Cell Lung Cancer

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Retention:   Samples With DNA
Description:

Blood sample collection, one 10 ml purple top EDTA tube, will be collected from each patient and control via venipuncture or from a central line.

Probability Sample

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.

Lung Cancer
Other: Mass Spectrometry
Levels of Cathepsin D (CD) and fatty acid synthase (FAS) will be measured using isobaric tag labeling coupled with mass spectrometry. RNA concentration will be measured using spectrophometer and purity will be analyzed.
  • Healthy Volunteers
    Non-smoking healthy volunteers
    Intervention: Other: Mass Spectrometry
  • Non-Small Cell Lung Cancer
    Patients with non-small cell lung cancer.
    Intervention: Other: Mass Spectrometry
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
October 2010
August 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00897234
2008NTLS094, 0809M47482
Yes
Robert Arthur Kratzke, M.D., Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
 
Principal Investigator: Robert A. Kratzke, MD Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
November 2010

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