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

Lung Cancer Clinical Trial

Official title:

Plasma Quantification of Cathepsin D and FAS in Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897234
• Other study ID #: 2008NTLS094
• Secondary ID: 0809M47482
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: August 21, 2014
• Start date: December 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Global microRNA expression	Measure global microRNA expression by microarray analysis using Illumina probes.	At Routine Follow-Up	No