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

Completed

• Conditions: Lung Cancer
• Interventions: Other: Mass Spectrometry

• Registration Number: NCT00897234
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2010-08
• Study Completion: 2010-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Mass Spectrometry	Non-smoking healthy volunteers
Non-Small Cell Lung Cancer	Mass Spectrometry	Patients with non-small cell lung cancer.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States