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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Mass Spectrometry

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.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center at University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Non-smoking healthy volunteers	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.
Non-Small Cell Lung Cancer; Patients with non-small cell 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of cathepsin D	Measure plasma CD levels in patients with non-small cell lung cancer and non-smoker healthy controls using mass spectrometry.	At Routine Follow-Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of fatty acid synthase (FAS)	Measure FAS levels in patients with non-small cell lung cancer and non-smoker healthy controls using mass spectrometry.	At Routine Follow-Up
Global microRNA expression	Measure global microRNA expression by microarray analysis using Illumina probes.	At Routine Follow-Up

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Robert A. Kratzke, MD, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: recurrent 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; stage I non-small cell lung cancer; stage II non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2008NTLS094; 0809M47482 (Other Identifier: IRB, University of Minnesota)