Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer
Conditions
Non-Small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Non-Small Cell lung cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.
Detailed Description
Single arm, open label, prospective, observational study of gefitinib treatment for locally advanced (stage IIIB) or IV (metastatic) or relapsed NSCLC patients.

Using DNA acquired from tumor tissue, sequencing and PNA-clamping for EGFR gene will be performed. The detection rates of EGFR mutation will be compared using paired samples.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- Locally advanced stage IIIB not suitable for curative therapy or stage IV (metastatic) disease or relapsed NSCLC

- ECOG Performance status 0~2.

- Written Informed Consent

- Female or male patients aged 18 years or over, eligible for treatment for NSCLC

Exclusion Criteria:

- Previous exposure to EGFR-TKI

- Concomitant use of other anti-cancer drugs with EGFR-TKI

- Patients without available Tumor DNA

- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)

- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

- Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
Location
Chonnam National University Hwasun Hospital
Hwasun-Gun, Jeonnam, Korea, Republic of
Status: Recruiting
Contact: Young-Chul Kim, MD, PhD - 82-61-379-7614 - kyc0923@jnu.ac.kr
Start Date
January 2013
Completion Date
June 2015
Sponsors
Chonnam National University Hospital
Source
Chonnam National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page