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
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Beijing
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Beijing, Beijing, China
- Research Site
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Guangdong
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Guangzhou, Guangdong, China
- Research Site
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Hebei
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Shijiazhuang, Hebei, China
- Research Site
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Henan
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Zhengzhou, Henan, China
- Research Site
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Hubei
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Wuhan, Hubei, China
- Research Site
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Jilin
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Changchun, Jilin, China
- Research Site
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Liaoning
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Shenyang, Liaoning, China
- Research Site
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Shandong
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Jinan, Shandong, China
- Research Site
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Shanghai
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Shanghai, Shanghai, China
- Research Site
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Shanxi
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Taiyuan, Shanxi, China
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Sichuan
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Chengdu, Sichuan, China
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Tianjin
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Tianjin, Tianjin, China
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Hong Kong, Hong Kong
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Chennai, India
- Research Site
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Kolkata, India
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Delhi
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Rohini, Delhi, India
- Research Site
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Gujarat
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Vadodara, Gujarat, India
- Research Site
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Kerala
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Kochi, Kerala, India
- Research Site
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Maharashtra
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Mumbai, Maharashtra, India
- Research Site
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Pune, Maharashtra, India
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Cebu City, Philippines
- Research Site
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Manila City, Philippines
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Pasay City, Philippines
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Quezon City, Philippines
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Taguig City, Philippines
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Chiayi, Taiwan
- Research Site
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Kaohsiung, Taiwan
- Research Site
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Tao-Yuan, Taiwan
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Bangkok, Thailand
- Research Site
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Chiang Mai, Thailand
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Songkla, Thailand
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Hanoi, Vietnam
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Ho Chi Minh City, Vietnam
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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 |
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Other: 1
EGFR mutation testing
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EGFR mutation test
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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.
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Samples will be tested after informed consent. Mutation results will be available within 1-3 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.