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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01185314
Recruitment Status : Completed
First Posted : August 19, 2010
Last Update Posted : August 8, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Procedure: Testing for mutation status Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1270 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: 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
Study Start Date : September 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1
EGFR mutation testing
Procedure: Testing for mutation status
EGFR mutation test




Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185314


Locations
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China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hebei
Research Site
Shijiazhuang, Hebei, China
China, Henan
Research Site
Zhengzhou, Henan, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Jilin
Research Site
Changchun, Jilin, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shandong
Research Site
Jinan, Shandong, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Shanxi
Research Site
Taiyuan, Shanxi, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Tianjin
Research Site
Tianjin, Tianjin, China
Hong Kong
Research Site
Hong Kong, Hong Kong
India
Research Site
Rohini, Delhi, India
Research Site
Vadodara, Gujarat, India
Research Site
Kochi, Kerala, India
Research Site
Mumbai, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
Chennai, India
Research Site
Kolkata, India
Philippines
Research Site
Cebu City, Philippines
Research Site
Manila City, Philippines
Research Site
Pasay City, Philippines
Research Site
Quezon City, Philippines
Research Site
Taguig City, Philippines
Taiwan
Research Site
Chiayi, Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Tao-Yuan, Taiwan
Thailand
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Songkla, Thailand
Vietnam
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
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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
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Responsible Party: Gerard Lynch, AstraZeneca
ClinicalTrials.gov Identifier: NCT01185314    
Other Study ID Numbers: D7913L00086
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: August 2011
Keywords provided by AstraZeneca:
NSCLC, EGFR mutation
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms