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Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer


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Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer


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.


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 childĀ¬bearing potential). Women of
childbearing potential must practice acceptable methods of birth control to prevent
pregnancy.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Detection rate of EGFR mutation

Outcome Description:

To prove higher detection rate of EGFR mutation with PNA clamping compared with sequencing

Outcome Time Frame:

two weeks

Safety Issue:

No

Principal Investigator

Young-Chul Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chonnam National University Hospital

Authority:

Korea: Institutional Review Board

Study ID:

ISSIRES0066

NCT ID:

NCT01767974

Start Date:

January 2013

Completion Date:

June 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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