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

NCT01767974 | Unknown

• 1 other identifier: ISSIRES0066
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Detection rate of EGFR mutation

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

  two weeks

Secondary Outcomes (1)

• Verification of PNA positive casese

  Two weeks

Study Arms (1)

Non-Small Cell Lung Cancer

Locally advanced stage IIIB or IV (metastatic) or Relapsed Non-Small Cell Lung Cancer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Locally advanced stage IIIB or IV (metastatic) or Relapsed Non-Small Cell Lung Cancer

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun-Gun, Jeollanam-do, 519-763, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA from lung cancer tumor tissue obtained by bronchoscopy, needle biopsy or surgical resection

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

• Young-Chul Kim, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Chul Kim, MD, PhD

CONTACT

82-61-379-7614; kyc0923@jnu.ac.kr

Ju-Mi Yoon, MS

CONTACT

82-61-379-7861; hhw55@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 15, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

KR (1)