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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), June 2009

First Received: May 9, 2009 Last Updated: June 16, 2009 History of Changes

Sponsor:	Masonic Cancer Center, University of Minnesota
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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	Genetic: proteomic profiling Other: laboratory biomarker analysis Other: mass spectrometry

Study Type:	Observational
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 National Cancer Institute (NCI):

Primary Outcome Measures:

Levels of cathepsin D [ Designated as safety issue: No ]

Secondary Outcome Measures:

Levels of fatty acid synthase [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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

Criteria

DISEASE CHARACTERISTICS:

Must meet one of the following criteria:
- Documented diagnosis of non-small cell lung cancer
  - Any stage
  - Any time point in the course of treatment
  - 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

PATIENT CHARACTERISTICS:

No 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

PRIOR CONCURRENT THERAPY:

Not specified

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	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

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:	Masonic Cancer Center at University of Minnesota ( Robert Arthur Kratzke )
Study ID Numbers:	CDR0000631983, UMN-2008NTLS094, 08O9M47482
Study First Received:	May 9, 2009
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00897234 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on February 08, 2010