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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Stanford University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568282
First Posted: December 6, 2007
Last Update Posted: October 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  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:


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 ]

Biospecimen Retention:   Samples With DNA
Whole blood

Estimated Enrollment: 100
Study Start Date: February 2007
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: phlebotomy
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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):

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

Inclusion Criteria (Controls):

  1. no known prior or active malignancy
  2. ability to sign informed consent
  3. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568282


Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Lisa Zhou    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

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00568282     History of Changes
Other Study ID Numbers: LUN0017
96710 ( Other Identifier: Stanford University Alternate IRB Approval Number )
LUN0017 ( Other Identifier: Stanford University )
4086 ( Other Identifier: Stanford IRB )
First Submitted: December 4, 2007
First Posted: December 6, 2007
Last Update Posted: October 25, 2013
Last Verified: October 2013

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