Clinical trial NCT01069835: Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)
Official title: Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Non small cell lung cancer
EGFR mutation
NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients from Oncological Dispensaries and Cancer Research Institutes

Brief summary: The overall aim of the study is:

To provide accurate and reliable information regarding NSCLC clinical management across Central Eastern European countries and Russia in order to detect unmet medical needs of this disease in terms of:

* Patient and hospital characteristics.
* Diagnostic and treatment approaches: initial and subsequent.
* Follow-up patterns in clinical management.
* Outcomes: symptoms, death, functionality, quality of life.
* Use of resources and burden on patients and health care systems. Addendum objective is to collect epidemiological data on EGFR mutation status (M+, M-) in the Russian population


Eligibility criteria: Inclusion Criteria:

* Confirmed NSCLC diagnosis (e.g.bronchoscopic biopsy or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between January 1st, 2010 and March 31st, 2010
* For Patient Reported Outcome (PRO) sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias.
* Tumour tissue samples (in paraffin-embedded blocks) suitable for EGFR mutation testing available.

Exclusion Criteria:

* Mixed histology of small cell and non-small cell lung cancer.

Primary outcomes:
measure: To assess the differences in patient characteristics, disease stage (differentiating between non-advanced disease, locally advanced disease, metastatic disease), and in clinical management across Central Eastern European countries and Russia
timeFrame: 24 months
Secondary outcomes:
measure: To detect differences in clinical outcomes and related factors among countries
timeFrame: 24 months
measure: To identify factors associated with clinical outcomes (patient, disease stage -see above- and clinical management related factors): predictive modelling for improved patient outcome
timeFrame: 24 months
measure: To identify factors associated with the different levels of functional status and quality of life
timeFrame: 24 months
measure: To compare the use of health care resources among countries
timeFrame: 24 months
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Research Site
state: Altaiskiy Krai
city: Birobidzhan
country: Russian Federation
facility: Research Site
state: EAO
city: Khabarovsk
country: Russian Federation
facility: Research Site
state: Khabarovskiy Krai
city: Khanty-Mansyisk
country: Russian Federation
facility: Research Site
state: Khanty-Mansyiskyi AO
city: Krasnodar
country: Russian Federation
facility: Research Site
state: Krasnodarskiy Krai
city: Vladivostok
country: Russian Federation
facility: Research Site
state: Primorskiy Krai
city: Yakutsk
country: Russian Federation
facility: Research Site
state: Republic of Sakha
city: Kazan
country: Russian Federation
facility: Research Site
state: Resp. of Tatarstan
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Belgorod
country: Russian Federation
facility: Research Site
city: Blagoveschensk
country: Russian Federation
facility: Research Site
city: Chita
country: Russian Federation
facility: Research Site
city: Engels
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Khimki
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orel
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Pyatigorsk
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Yuzno-Sakhalinsk
country: Russian Federation
facility: Research Site
city: Zhukovsky
country: Russian Federation
facility: Research Site
Study officials:
References:
citation: Tjulandin S, Imyanitov E, Moiseyenko V, Ponomarenko D, Gurina L, Koroleva I, Karaseva V. Prospective cohort study of clinical characteristics and management patterns for patients with non-small-cell lung cancer in the Russian Federation: EPICLIN-Lung. Curr Med Res Opin. 2015 Jun;31(6):1117-27. doi: 10.1185/03007995.2015.1036015. Epub 2015 May 8.