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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01767974

Acronym

SPACE

Enrollment

140

Registered

2013-01-15

Start date

2013-01-31

Completion date

2015-06-30

Last updated

2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell lung cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Detection rate of EGFR mutation	two weeks	To prove higher detection rate of EGFR mutation with PNA clamping compared with sequencing

Secondary

Measure	Time frame	Description
Verification of PNA positive casese	Two weeks	To analyze the Sequencing negative/PNA clamping positive group (where sample is available) with another sensitive technique COBAS test

Countries

South Korea

Contacts

Primary ContactYoung-Chul Kim, MD, PhD

kyc0923@jnu.ac.kr82-61-379-7614

Backup ContactJu-Mi Yoon, MS

hhw55@naver.com82-61-379-7861

Outcome results