Non Small Cell Lung CancerEPICLINNCT01069835
Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)
An observational study of Non Small Cell Lung Cancer, run by AstraZeneca at 31 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 840 participants
- Where
- 31 sitesRussia
- Study dates
- Feb 2010to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients from Oncological Dispensaries and Cancer Research Institutes
Who may be able to join
- 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.
Who cannot join
- Mixed histology of small cell and non-small cell lung cancer.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Russia31 sites
Research Site
Arkhangelsk
Research Site
Barnaul, Altaiskiy Krai
Research Site
Belgorod
Research Site
Birobidzhan, EAO
Research Site
Blagoveshchensk
Research Site
Chita
Research Site
Engel's
Research Site
Irkutsk
Research Site
Kazan', Resp. of Tatarstan
Research Site
Kemerovo
Research Site
Khabarovsk, Khabarovskiy Krai
Research Site
Khanty-Mansyisk, Khanty-Mansyiskyi AO
Research Site
Khimki
Research Site
Krasnodar, Krasnodarskiy Krai
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Obninsk
Research Site
Omsk
Research Site
Oryol
Research Site
Perm
Research Site
Pyatigorsk
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Tomsk
Research Site
Tula
Research Site
Vladivostok, Primorskiy Krai
Research Site
Volgograd
Research Site
Yakutsk, Sakha
Research Site
Yuzno-Sakhalinsk
Research Site
Zhukovsky
About this study
Official title: Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN
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
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non small cell lung cancer, EGFR mutation, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Non-small cell lung cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (4)
To detect differences in clinical outcomes and related factors among countries
Measured: 24 months
To identify factors associated with clinical outcomes (patient, disease stage -see above- and clinical management related factors): predictive modelling for improved patient outcome
Measured: 24 months
To identify factors associated with the different levels of functional status and quality of life
Measured: 24 months
To compare the use of health care resources among countries
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069835
- Sponsor's protocol ID
- NIS-ORU-IRE-2009/1
- Acronym
- EPICLIN
- Status last verified
- May 2015
- First submitted
- 15 Feb 2010
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN
- ClinicalTrials.gov ID
- NCT01069835
- Acronym / sponsor ID
- EPICLIN / NIS-ORU-IRE-2009/1
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non small cell lung cancer, EGFR mutation, NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Non-small cell lung cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients from Oncological Dispensaries and Cancer Research Institutes
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Mixed histology of small cell and non-small cell lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
To detect differences in clinical outcomes and related factors among countries
Time frame: 24 months
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
To identify factors associated with the different levels of functional status and quality of life
Time frame: 24 months
To compare the use of health care resources among countries
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Derived from this study: PubMed 25867537Tjulandin 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.
- Related InfoLink provided by the sponsor.
- CSR-NIS-ORU-IRE-2009-1.pdfLink provided by the sponsor.
- NIS-ORU-IRE-20091EPICLIN-LUNG-FinalProtocol-CEERussia-08122009Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by AstraZeneca at 31 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.