CClinicalTrials.gg
CompletedNCT01069835EPICLINUpdated May 19, 2015

Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)

An observational study in Non Small Cell Lung Cancer, sponsored by AstraZeneca. Completed at 31 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-19.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
840
Ages
18 Years and older
Sex
All
01

Study 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
02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Non small cell lung cancer
  • EGFR mutation
  • NSCLC
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 840 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cancer patients from Oncological Dispensaries and Cancer Research Institutes

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

Exclusion Criteria:

  • Mixed histology of small cell and non-small cell lung cancer.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
840 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Non-small cell lung cancer patients

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

Secondary outcomes

  1. To detect differences in clinical outcomes and related factors among countries

    Time frame: 24 months

  2. To identify factors associated with clinical outcomes (patient, disease stage -see above- and clinical management related factors): predictive modelling for improved patient outcome

    Time frame: 24 months

  3. To identify factors associated with the different levels of functional status and quality of life

    Time frame: 24 months

  4. To compare the use of health care resources among countries

    Time frame: 24 months

07

Study locations

31 sites
  • Research Site
    Barnaul, Altaiskiy Krai, Russian Federation
  • Research Site
    Birobidzhan, EAO, Russian Federation
  • Research Site
    Khabarovsk, Khabarovskiy Krai, Russian Federation
  • Research Site
    Khanty-Mansyisk, Khanty-Mansyiskyi AO, Russian Federation
  • Research Site
    Krasnodar, Krasnodarskiy Krai, Russian Federation
  • Research Site
    Vladivostok, Primorskiy Krai, Russian Federation
  • Research Site
    Yakutsk, Republic of Sakha, Russian Federation
  • Research Site
    Kazan, Resp. of Tatarstan, Russian Federation
  • Research Site
    Arkhangelsk, Russian Federation
  • Research Site
    Belgorod, Russian Federation
  • Research Site
    Blagoveschensk, Russian Federation
  • Research Site
    Chita, Russian Federation
  • Research Site
    Engels, Russian Federation
  • Research Site
    Irkutsk, Russian Federation
  • Research Site
    Kemerovo, Russian Federation
  • Research Site
    Khimki, Russian Federation
  • Research Site
    Moscow, Russian Federation
  • Research Site
    Nizhniy Novgorod, Russian Federation
  • Research Site
    Novosibirsk, Russian Federation
  • Research Site
    Obninsk, Russian Federation
  • Research Site
    Omsk, Russian Federation
  • Research Site
    Orel, Russian Federation
  • Research Site
    Perm, Russian Federation
  • Research Site
    Pyatigorsk, Russian Federation
  • Research Site
    Samara, Russian Federation
  • Research Site
    St. Petersburg, Russian Federation
  • Research Site
    Tomsk, Russian Federation
  • Research Site
    Tula, Russian Federation
  • Research Site
    Volgograd, Russian Federation
  • Research Site
    Yuzno-Sakhalinsk, Russian Federation
  • Research Site
    Zhukovsky, Russian Federation
08

References and documents

Publications

  • 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. PubMed 25867537 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01069835
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Feb 17, 2010
Start date
Feb 2010
Primary completion
Mar 2011
Completion
Mar 2012
Last update
May 19, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion