Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients

This study is currently recruiting participants.

Verified April 2011 by Stanford University

First Received on December 4, 2007. Last Updated on April 7, 2011 History of Changes

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00568282

Purpose

The primary aim of this study is to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients.

Condition	Intervention
Lung Cancer	Procedure: phlebotomy

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients (Old Title: Significance of CD44 and or Epithelial Specific Antigen Positive Cells in the Peripheral Blood of Lung Cancer Patients) (LUN0017)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Whole blood

Estimated Enrollment:	100
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Standard of care

Other Name: blood draw

Detailed Description:

The purpose of this study is to determine whether we can identify lung cancer cells circulating in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells such as CD44 and epithelial specific antigen.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients with advanced stage NSCLC who are either newly diagnosed, or who have evidence of disease progression.

Criteria

Inclusion Criteria:Inclusion Criteria:Inclusion Criteria (Cases):

Advanced stage (IIIB with malignant effusion or IV) histologically or cytologically confirmed NSCLC
Patients must be newly diagnosed (untreated) or have evidence of disease progression at the time of sample collection
ability to sign informed consent
at least 18 years of age

Inclusion Criteria (Controls):

no known prior or active malignancy
ability to sign informed consent
at least 18 years of age Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years

Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years

2. pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568282

Contacts

Contact: Lisa Zhou, MD

(650) 736-4112

yaya@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Lisa Zhou, MD 650-736-4112 yaya@stanford.edu
Contact: Cancer Clinical Trials Office (650) 498-7061
Principal Investigator: Heather A. Wakelee
Sub-Investigator: Dr Jessica S. Donington

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Heather A. Wakelee

Stanford University

More Information

No publications provided

Responsible Party:	Heather A. Wakelee, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00568282 History of Changes
Other Study ID Numbers:	SU-11052007-804, 96710, LUN0017
Study First Received:	December 4, 2007
Last Updated:	April 7, 2011
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Additional relevant MeSH terms:

Lung Neoplasms
Neoplastic Cells, Circulating
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

Lung Diseases
Respiratory Tract Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012