To Study the Changes in Protein in Lung Cells of Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (PIONEER)

August 5, 2011 updated by: AstraZeneca

A Molecular Epidemiology Study in Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC) of Adeno Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation Status

The purpose of this study is to study the changes in protein in lung cells of Asian patients with advanced non small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A molecular epidemiology study in Asian patients with advanced NSCLC of adeno histology to assess EGFR mutation status.

Study Type

Interventional

Enrollment (Anticipated)

1270

Phase

  • Not Applicable

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

  • China
    • Beijing
      • Beijing, Beijing, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
    • Hebei
      • Shijiazhuang, Hebei, China
        • Research Site
    • Henan
      • Zhengzhou, Henan, China
        • Research Site
    • Hubei
      • Wuhan, Hubei, China
        • Research Site
    • Jilin
      • Changchun, Jilin, China
        • Research Site
    • Liaoning
      • Shenyang, Liaoning, China
        • Research Site
    • Shandong
      • Jinan, Shandong, China
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China
        • Research Site
    • Shanxi
      • Taiyuan, Shanxi, China
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China
        • Research Site
    • Tianjin
      • Tianjin, Tianjin, China
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
  • India
      • Chennai, India
        • Research Site
      • Kolkata, India
        • Research Site
    • Delhi
      • Rohini, Delhi, India
        • Research Site
    • Gujarat
      • Vadodara, Gujarat, India
        • Research Site
    • Kerala
      • Kochi, Kerala, India
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Research Site
      • Pune, Maharashtra, India
        • Research Site
  • Philippines
      • Cebu City, Philippines
        • Research Site
      • Manila City, Philippines
        • Research Site
      • Pasay City, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
      • Taguig City, Philippines
        • Research Site
  • Taiwan
      • Chiayi, Taiwan
        • Research Site
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Tao-Yuan, Taiwan
        • Research Site
  • Thailand
      • Bangkok, Thailand
        • Research Site
      • Chiang Mai, Thailand
        • Research Site
      • Songkla, Thailand
        • Research Site
  • Vietnam
      • Hanoi, Vietnam
        • Research Site
      • Ho Chi Minh City, Vietnam
        • Research Site

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological or cytologically confirmed advanced Non small cell lung cancer of adeno histology NSCLC treatment naive Availability of cancer tissue or cytology sample

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study Previous enrollment in the present study

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
EGFR mutation testing
Procedure: Testing for mutation status
EGFR mutation test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EGFR mutation status of Asian patients with advanced NSCLC
Time Frame: Samples will be tested after informed consent. Mutation results will be available within 1-3 weeks.
Samples will be tested after informed consent. Mutation results will be available within 1-3 weeks.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Guy Yeoman, MBBS, MFPM, AstraZeneca
  • Study Chair: Robin Meng, MD, PhD, AstraZeneca Taiwan
  • Principal Investigator: Yang Pan-Chyr, MD, PhD, National Taiwan University College of Medicine

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

September 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimate)

August 19, 2010

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 5, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7913L00086

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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