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

January 11, 2013 updated by: Young-Chul Kim, Chonnam National University Hospital
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeonnam
      • Hwasun-Gun, Jeonnam, Korea, Republic of, 519-763
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kyu-Sik Kim, MD, PhD
        • Sub-Investigator:
          • In-Jae Oh, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISSIRES0066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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