Asia Pacific and Russia Diagnostic Study for EGFR Testing

NCT ID: NCT01788163

Last Updated: 2017-05-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-27

Study Completion Date

2016-06-20

Brief Summary

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Interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and Russia and will assess the current status of EGFR mutation testing, and the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA.

Detailed Description

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A diagnostic study to determine the prevalence of EGFR mutations in Asian and Russian patients with advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma histologies

Conditions

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EGFR Mutation Status in aNSCLC Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Locally advanced/metastatic NSCLC pats.

Patients with locally advanced (stage IIIA/B) or metastatic NSCLC who have not received any local or systemic chemotherapy, and are not eligible for curative treatment (including surgery and chemoradiotherapy)

Group Type OTHER

EGFR mutation test

Intervention Type GENETIC

EGFR mutation being tested in tissue and blood

Interventions

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EGFR mutation test

EGFR mutation being tested in tissue and blood

Intervention Type GENETIC

Other Intervention Names

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Determination of EGFR mutation done at the Pathology lab

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC
* Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naive (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
* Provision of diagnostic cancer tissue or cytology sample upon inclusion (surgical specimen, biopsy sample, or cytology sample is acceptable) and Provision of a routine blood (plasma) sample in China, Russia, Taiwan and Korea
* Patients aged 18 years and older

Exclusion Criteria

* 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 made it undesirable for the patient to participate in the study
* Pregnancy or breast-feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rose McCormack, PhD

Role: STUDY_DIRECTOR

AstraZeneca, PHB

Locations

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Research Site

Campbelltown, New South Wales, Australia

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Coffs Harbour, New South Wales, Australia

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Concord, New South Wales, Australia

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Tamworth, New South Wales, Australia

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Tweed Heads, New South Wales, Australia

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Wahroonga, New South Wales, Australia

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Brisbane, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Murdoch, Western Australia, Australia

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Beijing, , China

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Changsha, , China

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Changzhou, , China

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Chengdu, , China

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Chongqing, , China

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Foshan, , China

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Guangzhou, , China

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Hangzhou, , China

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Nanjing, , China

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Shanghai, , China

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Suzhou, , China

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Taiyuan, , China

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Wuhan, , China

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Zhengzhou, , China

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Jakarta, , Indonesia

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Surabaya, , Indonesia

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Kuala Lumpur, , Malaysia

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Arkhangelsk, , Russia

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Barnaul, , Russia

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Belgorod, , Russia

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Birobidzhan, , Russia

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Chelyabinsk, , Russia

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Chita, , Russia

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Irkutsk, , Russia

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Izhevsk, , Russia

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Kazan', , Russia

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Kemerovo, , Russia

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Khabarovsk, , Russia

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Khanty-Mansiysk, , Russia

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Krasnodar, , Russia

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Krasnoyarsk, , Russia

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Lipetsk, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Obninsk, , Russia

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Omsk, , Russia

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Oryol, , Russia

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Perm, , Russia

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Pyatigorsk, , Russia

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Rostov-on-Don, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Surgut, , Russia

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Tula, , Russia

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Ufa, , Russia

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Veliky Novgorod, , Russia

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Vladivostok, , Russia

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Volgograd, , Russia

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Yakutsk, , Russia

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Yaroslavl, , Russia

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Yuzhno-Sakhalinsk, , Russia

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Singapore, , Singapore

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Cheongju-si, , South Korea

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Daegu, , South Korea

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Seoul, , South Korea

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Kaohsiung City, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Chiang Mai, , Thailand

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Khon Kaen, , Thailand

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Patumwan Bangkok, , Thailand

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Countries

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Australia China Indonesia Malaysia Russia Singapore South Korea Taiwan Thailand

Related Links

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Other Identifiers

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D7913C00074

Identifier Type: -

Identifier Source: org_study_id

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