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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 219

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2007
• Primary Completion (Actual): March 8, 2017
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (Estimate): December 6, 2007

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lung Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: IRB-4086; 4086 (Stanford IRB); 96710 (Other Identifier: Stanford University Alternate IRB Approval Number); LUN0017 (Other Identifier: Stanford University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No