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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Chonnam National University Hospital
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01767974
First received: January 11, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Sequencing and PNA Clamping of EGFR Gene in Patients With Non-Small Cell Type Lung Cancer

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • Detection rate of EGFR mutation [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    To prove higher detection rate of EGFR mutation with PNA clamping compared with sequencing


Secondary Outcome Measures:
  • Verification of PNA positive casese [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    To analyze the Sequencing negative/PNA clamping positive group (where sample is available) with another sensitive technique COBAS test


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 140
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-Small Cell Lung Cancer
Locally advanced stage IIIB or IV (metastatic) or Relapsed Non-Small Cell Lung Cancer

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767974

Contacts
Contact: Young-Chul Kim, MD, PhD 82-61-379-7614 kyc0923@jnu.ac.kr
Contact: Ju-Mi Yoon, MS 82-61-379-7861 hhw55@naver.com

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun-Gun, Jeonnam, Korea, Republic of, 519-763
Contact: Young-Chul Kim, MD, PhD    82-61-379-7614    kyc0923@jnu.ac.kr   
Contact: Ju-Mi Yoon, MS    82-61-379-7861    hhw55@naver.com   
Sub-Investigator: Kyu-Sik Kim, MD, PhD         
Sub-Investigator: In-Jae Oh, MD, PhD         
Sponsors and Collaborators
Chonnam National University Hospital
AstraZeneca
Investigators
Principal Investigator: Young-Chul Kim, MD, PhD Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: Young-Chul Kim, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01767974     History of Changes
Other Study ID Numbers: ISSIRES0066
Study First Received: January 11, 2013
Last Updated: January 11, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Chonnam National University Hospital:
Non-Small Cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 29, 2014