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

NCT00717002 | Completed

• 1 other identifier: NS02/21/05
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To assess the use of immuno-separation techniques to enrich the tumor cell population in the blood of NSCLC patients.
2. 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.

Conditions

Non Small Cell Lung Cancer

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Patients with non small cell lung cancer.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ross Andrew Soo, MRCP, MB ChB

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

SG (1)