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). (ORTUS)
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| ClinicalTrials.gov Identifier: NCT02321046 |
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Recruitment Status :
Completed
First Posted : December 22, 2014
Last Update Posted : June 29, 2020
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| Condition or disease |
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| Non-Small Cell Lung Cancer |
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.
| Study Type : | Observational |
| Actual Enrollment : | 26 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | An epidemiOlogy Study to deteRmine the Prevalence of EGFR muTations in RUSsian Patients With Advanced NSCLC (ORTUS) |
| Actual Study Start Date : | September 2, 2015 |
| Actual Primary Completion Date : | June 28, 2019 |
| Actual Study Completion Date : | June 28, 2019 |
- EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment [ Time Frame: up to 18 months ]
- Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC. [ Time Frame: up to 18 months ]
- Disease information/diagnostic procedures [ Time Frame: up to 18 months ]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
- 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 [ Time Frame: up to 18 months ]
- Characteristics of the 1st line and subsequent lines of antitumor therapy [ Time Frame: up to 18 months ]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
- Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase) [ Time Frame: up to 18 months ]
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
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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): NCT02321046
| Russian Federation | |
| Research Site | |
| Khanti-Manskiysk, Russia, Russian Federation | |
| Research Site | |
| Novisibirsk, Russia, Russian Federation | |
| Research Site | |
| Arkhangelsk, Russian Federation | |
| Research Site | |
| Barnaul, Russian Federation | |
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| Chelyabinsk, Russian Federation | |
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| Irkutsk, Russian Federation | |
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| Kemerovo, Russian Federation | |
| Research Site | |
| Khabarovsk, Russian Federation | |
| Research Site | |
| Kirov, Russian Federation | |
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| Krasnodar, Russian Federation | |
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| Krasnoyarsk, Russian Federation | |
| Research Site | |
| Moscow, Russian Federation | |
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| Nizhniy Novgorod, Russian Federation | |
| Research Site | |
| Novosibirsk, Russian Federation | |
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| Obninsk, Russian Federation | |
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| Omsk, Russian Federation | |
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| Orenburg, Russian Federation | |
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| Rostov-on-Don, Russian Federation | |
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| Saint-Petersburg, Russian Federation | |
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| Samara, Russian Federation | |
| Research Site | |
| Tambov, Russian Federation | |
| Research Site | |
| Tomsk, Russian Federation | |
| Research Site | |
| Ufa, Russian Federation | |
| Research Site | |
| Vladivostok, Russian Federation | |
| Research Site | |
| Volgograd, Russian Federation | |
| Research Site | |
| Yuzhno-Sakhalinsk, Russian Federation | |
| Study Director: | Alexander Bedenkov, MCMD | AstraZeneca | |
| Principal Investigator: | Konstantin Lactionov, Professor | Russian Cancer Research Center named after N.N.Blokhin | |
| Principal Investigator: | Irina Demidova, PHD | Moscow City Clinical Cancer Hospital #62 |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT02321046 |
| Other Study ID Numbers: |
D133FR00101 |
| First Posted: | December 22, 2014 Key Record Dates |
| Last Update Posted: | June 29, 2020 |
| Last Verified: | June 2020 |
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Non-Small Cell Lung Cancer, NSCLC, Epidermal growth factor receptor, EGFR |
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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 |