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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC. | up to 18 months | |
| Disease information/diagnostic procedures | Date of the cytological verification of the NSCLC diagnosis. Disease stage and TNM classification. Morphological classification. Extent of the disease. Performance Status ECOG, including at diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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Target study population will be treatment-naive patients of both sexes, 18 years and older, with cytologically-verified advanced (stage IIIB-IV) non-squamous, mixed subtypes of NSCLC and NSCLC-NOS (Non-Small Cell Lung Cancer - Not Otherwise Specified), diagnosed before enrolment into the study, consented to participate in this non-interventional study, who visit the oncology hospitals/departments in the Russian Federation.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Bedenkov, MCMD | AstraZeneca | Study Director |
| Konstantin Lactionov, Professor | Russian Cancer Research Center named after N.N.Blokhin | Principal Investigator |
| Irina Demidova, PHD | Moscow City Clinical Cancer Hospital #62 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Khanti-Manskiysk | Russia | Russia | |||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Cytology and plasma samples
| up to 18 months |
| EGFR mutations profile in cytology and/or histology (depending on the availablility of samples) and plasma samples at the time of every progression or in 1.5 year follow up in case of no progression | up to 18 months |
| Characteristics of the 1st line and subsequent lines of antitumor therapy | 1st line and subsequent lines of therapy treatment, therapy regimen, medicines used for therapy (drugs by INN), for EGFRm+ patients - number of cycles of antitumor therapy, onset date, end date of each line | up to 18 months |
| Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase) | Treatment response/ progression of disease on every line of antitumor therapy: progressive disease, partial response, stable disease and complete response according to RECIST 1.1 evaluation and/or any other clinical assessment. Death: Disease-related or for other reasons | up to 18 months |
| Novisibirsk |
| Russia |
| Russia |
| Research Site | Arkhangelsk | Russia |
| Research Site | Barnaul | Russia |
| Research Site | Chelyabinsk | Russia |
| Research Site | Irkutsk | Russia |
| Research Site | Kemerovo | Russia |
| Research Site | Khabarovsk | Russia |
| Research Site | Kirov | Russia |
| Research Site | Krasnodar | Russia |
| Research Site | Krasnoyarsk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Nizhny Novgorod | Russia |
| Research Site | Novosibirsk | Russia |
| Research Site | Obninsk | Russia |
| Research Site | Omsk | Russia |
| Research Site | Orenburg | Russia |
| Research Site | Rostov-on-Don | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Samara | Russia |
| Research Site | Tambov | Russia |
| Research Site | Tomsk | Russia |
| Research Site | Ufa | Russia |
| Research Site | Vladivostok | Russia |
| Research Site | Volgograd | Russia |
| Research Site | Yuzhno-Sakhalinsk | Russia |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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