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Sponsored by: |
National University Hospital, Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00717847 |
We hypothesize that Epidermal growth factor receptor tyrosine kinase inhibitors modulate tumor changes that may be reflected in the alteration of serum proteins.
Study objectives are:
Condition |
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Non Small Cell Lung Cancer |
Study Type: | Observational |
Study Design: | Case-Only, Cross-Sectional |
Official Title: | A Study of Serum Protein Profiling in Patients With Non-Small Cell Lung Cancer Treated With Gefitinib or Erlotinib |
Study Start Date: | February 2006 |
Groups/Cohorts |
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1
Any patient with NSCLC receiving erlotinib or gefitinib
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Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.
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Background:
Although some success has been achieved in identifying Epidermal growth factor receptor (EGFR) mutations as a molecular predictive marker of response in patients with non-small cell lung cancer (NSCLC), this strategy is likely only to be limited as not all responding patients have a mutation in their tumor and conversely, not all patients with a mutation were responders. Furthermore, as the development of resistance to EGFR tyrosine kinase inhibitors (TKI) such as gefitinib, erlotinib is inevitable and poses a major clinical problem due to limited therapeutic options, the identification of a molecular profile that could predict sensitivity to erlotinib or gefitinib is warranted.
Hypothesis:
Using serum as an easily accessible biological fluid, we hypothesize that EGFR TKIs modulate tumor changes that may be reflected in the alteration of serum proteins.
Objectives:
Significance:
An extensive profiling of the molecular circuitry affected by EGFR TKIs would be helpful in understanding the response and side effects of patients with NSCLC treated with erlotinib or gefitinib and could guide therapy and thus improve patient outcome.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Any patient with NSCLC receiving erlotinib or gefitinib. Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.
Inclusion Criteria:
Contact: Ross Andrew Soo, MBBS | 65-6772-4624 | Ross_Soo@nuh.com.sg |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore | |
Contact: Ross Andrew Soo, MBBS 65-6772-4624 Ross_Soo@nuh.com.sg | |
Principal Investigator: Ross Andrew Soo, MBBS |
Principal Investigator: | Ross Andrew Soo, MBBS | National University Hospital, Singapore |
Study ID Numbers: | NS01/19/05 |
Study First Received: | July 17, 2008 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00717847 |
Health Authority: | Singapore: Domain Specific Review Boards |
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Gefitinib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |