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

Non-Small Cell Lung Cancer Clinical Trial

— SPACE  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01767974
• Other study ID #: ISSIRES0066
• Status: Unknown status
• Phase: N/A
• First received: January 11, 2013
• Last updated: January 11, 2013
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2013
• Source: Chonnam National University Hospital
• Contact: Young-Chul Kim, MD, PhD
• Phone: 82-61-379-7614
• Email: kyc0923[@]jnu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 140
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-Gun	Jeonnam

Sponsors (2)

Lead Sponsor	Collaborator
Chonnam National University Hospital	AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of EGFR mutation	To prove higher detection rate of EGFR mutation with PNA clamping compared with sequencing	two weeks
Secondary	Verification of PNA positive casese	To analyze the Sequencing negative/PNA clamping positive group (where sample is available) with another sensitive technique COBAS test	Two weeks