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

Sponsor:	Masonic Cancer Center, University of Minnesota
Information provided by:	Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00897234

Purpose

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.

Condition	Intervention
Lung Cancer	Other: Mass Spectrometry

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Plasma Quantification of Cathepsin D and FAS in Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Biospecimen Retention: Samples With DNA

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.

Enrollment:	84
Study Start Date:	December 2008
Study Completion Date:	October 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897234

Locations

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

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Principal Investigator:

Robert A. Kratzke, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Robert Arthur Kratzke, M.D., Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00897234 History of Changes
Other Study ID Numbers:	2008NTLS094, 0809M47482
Study First Received:	May 9, 2009
Last Updated:	November 22, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:

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

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2012