Detection of EGFR Mutations in the Blood of Patients With Non-small Cell Lung Cancer: a Feasibility Study

This study has been completed.
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00717002
First received: July 14, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The overall objective of the study is to assess the feasibility of the use of blood for the detection of EGFR mutations in patients with non-small cell lung cancer (NSCLC)

Specific aims are:

  1. To assess the use of immuno-separation techniques to enrich the tumor cell population in the blood of NSCLC patients.
  2. To assess the use of denaturing high performance liquid chromatography (DHPLC) assay for the detection of EGFR mutations in the blood of NSCLC patients.

Condition
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Detection of EGFR Mutations in the Blood of Patients With Non-small Cell Lung Cancer: a Feasibility Study

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Study Start Date: February 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients from Group 1 will undergo thoracoscopy as part of their routine clinical management to drain off excess pleural fluid. Even though taking a sample of the tumour tissue present on the pleural/ lining of the lung may not routinely form part of a routine thoracoscopy, it will be obtained for the study and sent to the laboratory for testing.
2
Patients from Group 2 should have tumour samples obtained previously for diagnosis, and these will be obtained from the Department of Pathology. If they are undergoing thoracoscopy as part of their routine clinical management, a sample of the tumour tissue present on the pleural/ lining of the lung will also be obtained during the procedure and sent to the laboratory for testing.

Detailed Description:

The oral tyrosine kinase (TK) inhibitors of Epidermal Growth Factor Receptor (EGFR), gefitinib and erlotinib, have produced dramatic responses, encouraging response rates and possibly improved survival in a subset of NSCLC patients. Evidence suggests that somatic EGFR mutations in the tumor are at present the single most reliable biological marker of predicting response to EGFR TK inhibitors. In addition, these mutations may be an early event in the pathogenesis of NSCLC in a subset of patients. Unfortunately, the technology of EGFR mutations sequencing incurs high costs and requires sufficient tissue, which is often a problem in NSCLC. We hypothesize that EGFR mutations can be detected in the blood and propose a study to determine the feasibility of detecting EGFR mutations in the blood of NSCLC patients. We will approach newly diagnosed NSCLC patients as well as patients who are known to be responding to the oral TK inhibitors. We will perform EGFR mutations on the tumors. For the blood, we will use new immuno-separation techniques to isolate tumor cells and perform denaturing high performance liquid chromatography to detect EGFR mutations. If we prove that it is feasible to detect the mutations in the blood, we will follow up with a validation study. Many applications can result if our hypothesis holds true: 1) it will be proof of principle that our technique can effectively isolate and detect somatic mutations in circulating tumor cells, 2) it will be a simple way to overcome the problem of insufficient tumor samples, 3) it can be used for early detection of lung cancer if EGFR mutations proves to be important in pathogenesis in a subset of patients and 4) the technology can be extended to detect new mutations in patients who become resistant to oral TK inhibitors which can lead to new targeted therapies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients from Group 1 will undergo thoracoscopy as part of their routine clinical management to drain off excess pleural fluid. Even though taking a sample of the tumour tissue present on the pleural/ lining of the lung may not routinely form part of a routine thoracoscopy, it will be obtained for the study and sent to the laboratory for testing.

Patients from Group 2 should have tumour samples obtained previously for diagnosis, and these will be obtained from the Department of Pathology. If they are undergoing thoracoscopy as part of their routine clinical management, a sample of the tumour tissue present on the pleural/ lining of the lung will also be obtained during the procedure and sent to the laboratory for testing.

Criteria

Patients with non small cell lung cancer.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00717002

Locations
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Ross Andrew Soo, MRCP, MB ChB National University Hospital, Singapore
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00717002     History of Changes
Other Study ID Numbers: NS02/21/05
Study First Received: July 14, 2008
Last Updated: December 10, 2013
Health Authority: Singapore: Domain Specific Review Boards

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

ClinicalTrials.gov processed this record on September 22, 2014