A Study of Serum Protein Profiling in Patients With Non-Small Cell Lung Cancer Treated With Gefitinib or Erlotinib

NCT00717847 | Completed

• 1 other identifier: NS01/19/05
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• To establish serum proteomic changes in patients with non-small cell lung cancer (NSCLC) receiving erlotinib or gefitinib.
• To identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or resistance in NSCLC patients with and without EGFR mutations.
• To study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with serum protein profile.

Conditions

Non Small Cell Lung Cancer

Study Arms (2)

1

Any patient with NSCLC receiving erlotinib or gefitinib

2

Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.

Eligibility Criteria

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

Study Population

Any patient with NSCLC receiving erlotinib or gefitinib. Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.

You may qualify if:

• Any patient with NSCLC receiving erlotinib or gefitinib.
• Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.
• Age ≥ 18 years
• Written informed consent.

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, MBBS

  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 17, 2008
• First Posted: July 18, 2008
• Study Start: February 1, 2006
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

SG (1)