An epidemiOlogy Study to deteRmine the Prevalence of EGFR (Epidermal Growth Factor Receptor) muTations in RUSsian Patients With Advanced NSCLC (Non-Small Cell Lung Cancer).

NCT ID: NCT02321046

Last Updated: 2020-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-02

Study Completion Date

2019-06-28

Brief Summary

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This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia.

Detailed Description

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This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

It is planned to enrol approximately 300 subjects in Russian Federation. Approximately 60 EGFR m+ (mutation-positive) patients will be followed for 1.5 years.

EGFR mutations rate before treatment in cytology and plasma samples in treatment-naive patients with advanced NSCLC in Russia is considered as the primary outcome variable in this study.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Cytologically verified advanced (stages IIIB - IV) nonsquamous (adenocarcinoma, large cell carcinoma) and mixed subtypes of NSCLC and NSCLC-NOS), diagnosed before enrolment into the study
* Quality and quantity of the cytological sample material meeting the requirements of the molecular-genetic testing
* No previous/ ongoing treatment for NSCLC at the moment of recruitment

Exclusion Criteria

* Squamous NSCLC cytologically confirmed subtype of cancer
* Any medical condition which on the opinion of the investigator may interfere the patient's participation in the study
* Quality and quantity of the cytological sample material insufficient for the molecular-genetic testing
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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Alexander Bedenkov, MCMD

Role: STUDY_DIRECTOR

AstraZeneca

Konstantin Lactionov, Professor

Role: PRINCIPAL_INVESTIGATOR

Russian Cancer Research Center named after N.N.Blokhin

Irina Demidova, PHD

Role: PRINCIPAL_INVESTIGATOR

Moscow City Clinical Cancer Hospital #62

Locations

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Research Site

Khanti-Manskiysk, Russia, Russia

Site Status

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Novisibirsk, Russia, Russia

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Arkhangelsk, , Russia

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Barnaul, , Russia

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Chelyabinsk, , Russia

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Irkutsk, , Russia

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Kemerovo, , Russia

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Khabarovsk, , Russia

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Kirov, , Russia

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Krasnodar, , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Novosibirsk, , Russia

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Obninsk, , Russia

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Omsk, , Russia

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Orenburg, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Tambov, , Russia

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Tomsk, , Russia

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Ufa, , Russia

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Vladivostok, , Russia

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Volgograd, , Russia

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Yuzhno-Sakhalinsk, , Russia

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Countries

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Russia

Other Identifiers

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D133FR00101

Identifier Type: -

Identifier Source: org_study_id

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