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Epidermal Growth Factor Receptor Mutations in the Blood of Patients With Advanced Non-Small Cell Lung Cancer

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 July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00899756
First Posted: May 12, 2009
Last Update Posted: July 8, 2009
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations in the blood of patients with advanced non-small cell lung cancer.


Condition Intervention
Lung Cancer Genetic: molecular diagnostic method Genetic: mutation analysis

Study Type: Observational
Official Title: Study of Mutations of Epidermal Growth Factor Receptor in the Blood of Patients With Advanced Non Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Existence of epidermal growth factor receptor (EGFR) mutations in peripheral blood
  • Frequency of EGFR mutation
  • Correlation of the presence of EGFR mutation in blood with EFGR mutation in primary or metastatic tumor tissue

Estimated Enrollment: 50
Study Start Date: June 2006
Detailed Description:

OBJECTIVES:

  • Determine if epidermal growth factor receptor (EGFR) mutation exists in the peripheral blood of patients with advanced non-small cell lung cancer (NSCLC).
  • Estimate the frequency of EGFR mutation in these patients.
  • Correlate the presence of EGFR mutation in blood with EGFR mutation in primary or metastatic NSCLC tumor block.

OUTLINE: Patients undergo blood collection for analysis of epidermal growth factor receptor mutation by DNA sequencing.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced non-small cell lung cancer
  • Must have available tumor tissue block

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  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): NCT00899756


Locations
Singapore
Johns Hopkins Singapore International Medical Centre Recruiting
Singapore, Singapore, 308433
Contact: Alex Y. Chang, MD    65-6880-2222    alexchang@imc.jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Alex Y. Chang, MD Johns Hopkins Singapore International Medical Centre
  More Information

ClinicalTrials.gov Identifier: NCT00899756     History of Changes
Other Study ID Numbers: CDR0000491609
JHOC-JS0538
JHOC-06-03-07-01
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: July 8, 2009
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action