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 because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899756
First received: May 9, 2009
Last updated: July 7, 2009
Last verified: July 2009
  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 [ Designated as safety issue: No ]
  • Frequency of EGFR mutation [ Designated as safety issue: No ]
  • Correlation of the presence of EGFR mutation in blood with EFGR mutation in primary or metastatic tumor tissue [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Alex Y. Chang, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00899756     History of Changes
Other Study ID Numbers: CDR0000491609, JHOC-JS0538, JHOC-06-03-07-01
Study First Received: May 9, 2009
Last Updated: July 7, 2009
Health Authority: Unspecified

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

ClinicalTrials.gov processed this record on July 23, 2014