Lung CancerNCT01752647
CT Screening For Lung Cancer in High Risk Patients: the Russian Study.
A study testing Low dose computed tomography in people with Lung Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 2 sites in Russia.
Trial summary
This prospective cohort trial was planned to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Low dose computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 2 sitesRussia
- Study dates
- Nov 2012to Sep 2016
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-75 years
- 30 or more pack-years of cigarette smoking history
- Former smokers: quit smoking within the previous 10 years
- Ability to tolerate CT procedure
- Signed informed consent
Who cannot join
- Any cancer other than nonmelanoma skin cancer or carcinoma in situ in the 5 years prior to eligibility assessment
- Severe uncontrolled heart, vascular, respiratory or endocrine pathology.
- Life-expectancy less than 1 year
- History of lung cancer
- History of lung surgery.
- Acute respiratory disease
Show all 10Show fewer
- Hemoptysis.
- Weight loss more than 10 kg in the 12 months prior to eligibility assessment
- Participation in other cancer clinical trial
- Chest CT examination in the 12 months prior to eligibility assessment.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Semashko City Clinical Hospital #2
Samara, Samara Oblast, 443008
Samara Regional Oncology Dispansery
Samara, Samara Oblast, 443031
About this study
Official title: Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.
This prospective cohort trial was planned to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking.
Read the detailed description
Low dose computer tomography (LDCT) showed promising results in recently published studied. Lung cancer screening programs with fluorography introduced in USSR in 70s-80s showed shift to earlier stages with no data on mortality. No other studies or programs on lung cancer screening were introduced in Russia since then.
The purpose of this study is to assess the feasibility of establishing a lung cancer screening program in Russian Federation using LDCT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. This cohort prospective study is planned to enroll at least 500 current or former smokers.
Patients will be screened by LDCT scan at baseline with recommendation to perform follow-up in case of any positive result. For nodes more than 10 mm full clinical examination is recommended. For nodes 3-9.9 mm follow-up scans in 1, 3 or 6 months is recommended. For nodes smaller than 3 mm and negative results annual LDCT is recommended. Patient with positive results will be followed until final clinical diagnosis.
Secondary outcomes include:
- Lung cancer diagnoses
- Lung cancer and overall mortality
- Quality of life assessment
- Complications of diagnostic and surgical procedures following a positive result.
- Comparison of independent radiological evaluation of scans.
- Conditions
- Lung Cancer
- Being tested
- Low dose computed tomography
- Keywords
- lung cancer, screening, low dose, computed tomography
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose computed tomographyProcedure or surgery
Also called CT scan, LDCT scan
Low dose computed tomography scan
| Study group | Role | What they receive |
|---|---|---|
| Low dose computed tomography | Experimental | Patients will have one baseline LDCT scan. Receives: Procedure: Low dose computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the time period for recruitment of 500 participants in LDCT screening study.
Primary outcome measure is to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. The main concern comes from the possibility to recruit participant for screening as small amount of information is available about lung cancer screening options for high-risk population and general practitioners in different regions of the country.
Measured: 3 months
Secondary outcomes (5)
Lung cancer detection rate
Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.
Measured: One year
All-cause mortality
Assess all-cause mortality mortality within next 5 years.
Measured: 5 years
Lung cancer mortality
Assess lung cancer mortality in the screened group within next 5 years.
Measured: 5 years
Nodule detection rate
Estimate nodule detection rate, types and sizes of lung nodules found.
Measured: 3 months
Recruitment strategies
Assess the efficacy of different recruitment strategy in this study. Information about the study was shared between general practitioners, radiologists, pulmonologists, thoracic oncologist.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexei Barchuk, MD PhD, Study chair, N.N. Petrov National Medical Research Center of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752647
- Sponsor's protocol ID
- RLCT-01
- Status last verified
- Sep 2019
- First submitted
- 13 Dec 2012
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Low Dose Computed Tomography for Lung Cancer Screening in Asymptomatic High-risk Patients.
- ClinicalTrials.gov ID
- NCT01752647
- Acronym / sponsor ID
- RLCT-01
- Conditions
- Lung Cancer
- Keywords
- lung cancer, screening, low dose, computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Dec 2012 (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.
This prospective cohort trial was planned to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking.
Detailed description
Low dose computer tomography (LDCT) showed promising results in recently published studied. Lung cancer screening programs with fluorography introduced in USSR in 70s-80s showed shift to earlier stages with no data on mortality. No other studies or programs on lung cancer screening were introduced in Russia since then.
The purpose of this study is to assess the feasibility of establishing a lung cancer screening program in Russian Federation using LDCT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. This cohort prospective study is planned to enroll at least 500 current or former smokers.
Patients will be screened by LDCT scan at baseline with recommendation to perform follow-up in case of any positive result. For nodes more than 10 mm full clinical examination is recommended. For nodes 3-9.9 mm follow-up scans in 1, 3 or 6 months is recommended. For nodes smaller than 3 mm and negative results annual LDCT is recommended. Patient with positive results will be followed until final clinical diagnosis.
Secondary outcomes include:
- Lung cancer diagnoses
- Lung cancer and overall mortality
- Quality of life assessment
- Complications of diagnostic and surgical procedures following a positive result.
- Comparison of independent radiological evaluation of scans.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose computed tomography | Experimental | Procedure: Low dose computed tomographyPatients will have one baseline LDCT scan. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50-75 years
- 30 or more pack-years of cigarette smoking history
- Former smokers: quit smoking within the previous 10 years
- Ability to tolerate CT procedure
- Signed informed consent
Key exclusion criteria (10 listed)
- Any cancer other than nonmelanoma skin cancer or carcinoma in situ in the 5 years prior to eligibility assessment
- Severe uncontrolled heart, vascular, respiratory or endocrine pathology.
- Life-expectancy less than 1 year
- History of lung cancer
- History of lung surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose computed tomographyAlso: CT scan, LDCT scanLow dose computed tomography scan | Procedure or surgery | Low dose computed tomography |
Primary outcome
Estimate the time period for recruitment of 500 participants in LDCT screening study.
Time frame: 3 months
Primary outcome measure is to assess the feasibility of establishing a lung cancer screening program in Russian Federation using low-dose CT scanning in asymptomatic patients with at least a 30 pack-year history of cigarette smoking. The main concern comes from the possibility to recruit participant for screening as small amount of information is available about lung cancer screening options for high-risk population and general practitioners in different regions of the country.
5 secondary outcomes
Lung cancer detection rate
Time frame: One year
All-cause mortality
Time frame: 5 years
Lung cancer mortality
Time frame: 5 years
Nodule detection rate
Time frame: 3 months
Recruitment strategies
Time frame: 3 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 4 Sep 2019.
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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.
Alexei Barchuk, MD PhD study chair
N.N. Petrov National Medical Research Center of Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose computed tomography in people with Lung Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 2 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 5 inclusion and 10 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 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Estimate the time period for recruitment of 500 participants in LDCT screening study. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2019.