Stage III Non-small Cell Lung CancerNCT05157503
Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"
An observational study of Stage III Non-small Cell Lung Cancer, run by Autonomous Non-Profit Organization National Society of Onco-Pulmonologists at 1 site in Russia.
Trial summary
In connection with the transition to the 8th version of the classification of lung cancer according to the TNM system, there are currently no precise epidemiological data on stage III NSCLC, clinical characteristics of patients in this group, approaches to therapy and treatment results in the Russian Federation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stage III Non-small Cell Lung Cancer
- How many people
- 1 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jan 2020to 31 Mar 2023
- How long will I take part?
- 3 Years
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with morphologically proven stage III non-small cell lung cancer
Who may be able to join
- stage III non-small cell lung cancer
Who cannot join
- the rest of the disease stage
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
National Medical Research Center of Oncology. N. N. Blokhin
Moscow, 115478
About this study
Official title: "Epidemiology, Approaches to the Diagnosis and Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"
In connection with the transition to the 8th version of the classification of lung cancer according to the TNM system, there are currently no precise epidemiological data on stage III NSCLC, clinical characteristics of patients in this group, approaches to therapy and treatment results in the Russian Federation. The published statistics only provide information on the overall incidence of stage III lung, trachea and bronchial cancer, which is about 40%. This observational study will make it possible to characterize the Russian population of stage III non-small cell lung cancer patients, approaches to choosing a treatment option for stage III NSCLC and the outcomes of this treatment in real clinical practice.
- Conditions
- Stage III Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine clinical and morphological groups
- gender ratio (husband, wife)
- smoking status (smoker, non-smoker, past smoker)
- proportional distribution: squamous cell, adenocarcinoma, dimorphic cancer, others)
- how many patients with mediastinal lymph node involvement: (N0, N1, N2, N3)
- detection frequency: PDL (PDL <1, PDL> 1, PDL <49, PDL> 50), EGFR (EGFR + (19.24 exon) EGFR-), (ALK +, ALK -), (ROS-1 +, ROS-1 -) Get information about regional algorithms
- Variants of treatment tactics:
Percentage:
- Surgery
- Chemotherapy
-Diagnostic algorithm:
- Morphological verification frequency b. The frequency of confirmation of metastatic lesions within the thoracic lymph nodes c. F
Measured: 10/01/2023
Secondary outcomes (3)
Explore clinical approaches
- Percentage of treatment options depending on:
- histological type
- squamous
- adenocarcinoma
- dimorphic
- 3 A st
- 3B st
Measured: 10/01/2023
Diagnostic algorithm:
- from a variant of molecular genetic disorders
- PDL <1
- PDL> 1
- PDL <49
- PDL> 50
- EGFR +
Measured: 10/01/2023
Percentage of treatment options
from functional status
- ECOG 1
- only surgical treatment
- surgical + drug treatment
- surgical + drug treatment + radiation therapy
- drug treatment
- drug treatment + radiation therapy
- radiation therapy
- ECOG 2
- only surgical treatment
- surgical + drug treatment
- surgical + drug treatment + radiation therapy
- drug treatment
- drug treatment + radiation therapy
- radiation therapy
- ECOG 3
- only surgical treatment
- surgical + drug treatment
- surgical + drug treatment + radiation therapy
- drug treatment
- drug treatment + radiation therapy
- radiation therapy
Measured: 10/01/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start10 Jan 2020
- Primary completion15 Jan 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Non-small Cell 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Autonomous Non-Profit Organization National Society of Onco-Pulmonologists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157503
- Sponsor's protocol ID
- 4
- Status last verified
- Dec 2021
- First submitted
- 21 Sep 2020
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Epidemiology, Approaches to the Diagnosis and Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"
- ClinicalTrials.gov ID
- NCT05157503
- Acronym / sponsor ID
- 4
- Conditions
- Stage III Non-small Cell Lung Cancer
- Keywords
- non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Autonomous Non-Profit Organization National Society of Onco-PulmonologistsUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 15 Dec 2021 (actual)
- 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.
In connection with the transition to the 8th version of the classification of lung cancer according to the TNM system, there are currently no precise epidemiological data on stage III NSCLC, clinical characteristics of patients in this group, approaches to therapy and treatment results in the Russian Federation. The published statistics only provide information on the overall incidence of stage III lung, trachea and bronchial cancer, which is about 40%. This observational study will make it possible to characterize the Russian population of stage III non-small cell lung cancer patients, approaches to choosing a treatment option for stage III NSCLC and the outcomes of this treatment in real clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with morphologically proven stage III non-small cell lung cancer
Key inclusion criteria (1 listed)
- stage III non-small cell lung cancer
Key exclusion criteria (1 listed)
- the rest of the disease stage
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
Examine clinical and morphological groups
Time frame: 10/01/2023
* gender ratio (husband, wife) * smoking status (smoker, non-smoker, past smoker) * proportional distribution: squamous cell, adenocarcinoma, dimorphic cancer, others) * how many patients with mediastinal lymph node involvement: (N0, N1, N2, N3) * detection frequency: PDL (PDL <1, PDL> 1, PDL <49, PDL> 50), EGFR (EGFR + (19.24 exon) EGFR-), (ALK +, ALK -), (ROS-1 +, ROS-1 -) Get information about regional algorithms * Variants of treatment tactics: Percentage: a. Surgery v. Chemotherapy -Diagnostic algorithm: a. Morphological verification frequency b. The frequency of confirmation of metastatic lesions within the thoracic lymph nodes c. F
3 secondary outcomes
Explore clinical approaches
Time frame: 10/01/2023
Diagnostic algorithm:
Time frame: 10/01/2023
Percentage of treatment options
Time frame: 10/01/2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Non-small Cell Lung Cancer, run by Autonomous Non-Profit Organization National Society of Onco-Pulmonologists at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantin Laktionov, Professor (+7-903-170-97-95, lkoskos@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine clinical and morphological groups (time frame: 10/01/2023). 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 15 Dec 2021.