Non-Small Cell Lung Cancer Clinical Trial
— ORTUSOfficial title:
An epidemiOlogy Study to deteRmine the Prevalence of EGFR muTations in RUSsian Patients With Advanced NSCLC (ORTUS)
NCT number | NCT02321046 |
Other study ID # | D133FR00101 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2, 2015 |
Est. completion date | June 28, 2019 |
Verified date | June 2020 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | June 28, 2019 |
Est. primary completion date | June 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Research Site | Arkhangelsk | |
Russian Federation | Research Site | Barnaul | |
Russian Federation | Research Site | Chelyabinsk | |
Russian Federation | Research Site | Irkutsk | |
Russian Federation | Research Site | Kemerovo | |
Russian Federation | Research Site | Khabarovsk | |
Russian Federation | Research Site | Khanti-Manskiysk | Russia |
Russian Federation | Research Site | Kirov | |
Russian Federation | Research Site | Krasnodar | |
Russian Federation | Research Site | Krasnoyarsk | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Nizhniy Novgorod | |
Russian Federation | Research Site | Novisibirsk | Russia |
Russian Federation | Research Site | Novosibirsk | |
Russian Federation | Research Site | Obninsk | |
Russian Federation | Research Site | Omsk | |
Russian Federation | Research Site | Orenburg | |
Russian Federation | Research Site | Rostov-on-Don | |
Russian Federation | Research Site | Saint-Petersburg | |
Russian Federation | Research Site | 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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment | up to 18 months | ||
Secondary | Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC. | up to 18 months | ||
Secondary | 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 | up to 18 months | |
Secondary | 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 | ||
Secondary | 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 | |
Secondary | 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 |
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