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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00568282
First received: December 4, 2007
Last updated: October 23, 2013
Last verified: October 2013

December 4, 2007
October 23, 2013
February 2007
July 2014   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00568282 on ClinicalTrials.gov Archive Site
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Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients
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)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Non-Probability Sample

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

Lung Cancer
Procedure: phlebotomy
Standard of care
Other Name: blood draw
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2014
July 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
Yes
United States
 
NCT00568282
LUN0017, 96710, LUN0017, 4086
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Heather A. Wakelee Stanford University
Stanford University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP