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

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ClinicalTrials.gov Identifier: NCT00568282
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Lung Cancer Procedure: phlebotomy

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.
Study Design
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Study Type : Observational
Actual Enrollment : 219 participants
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)
Actual Study Start Date : February 2007
Actual Primary Completion Date : March 8, 2017
Actual Study Completion Date : July 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Intervention Details:
  • Procedure: phlebotomy
    Standard of care
    Other Name: blood draw

Outcome Measures
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Primary Outcome Measures :
  1. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Heather A. Wakelee Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00568282    
Other Study ID Numbers: IRB-4086
96710 ( Other Identifier: Stanford University Alternate IRB Approval Number )
LUN0017 ( Other Identifier: Stanford University )
4086 ( Other Identifier: Stanford IRB )
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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