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Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"

Sponsor
Autonomous Non-Profit Organization National Society of Onco-Pulmonologists (Other)
Overall Status
Recruiting
CT.gov ID
NCT05157503
Collaborator
(none)
1
Enrollment
1
Location
38.6
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    "Epidemiology, Approaches to the Diagnosis and Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"
    Actual Study Start Date :
    Jan 10, 2020
    Anticipated Primary Completion Date :
    Jan 15, 2023
    Anticipated Study Completion Date :
    Mar 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Examine clinical and morphological groups [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

    Secondary Outcome Measures

    1. Explore clinical approaches [10/01/2023]

      Percentage of treatment options depending on: a. histological type squamous adenocarcinoma dimorphic 3 A st 3B st

    2. Diagnostic algorithm: [10/01/2023]

      v. from a variant of molecular genetic disorders PDL <1 PDL> 1 PDL <49 PDL> 50 EGFR +

    3. Percentage of treatment options [10/01/2023]

      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

    Other Outcome Measures

    1. -Evaluate the frequency of decision-making as a standard practice vs with an individual decision [10/01/2023]

      Percentage of treatment options depending on: a. The nature of the progression oligo progression systemic progression b. Prior treatment options v. after surgical treatment d. Afte

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • stage III non-small cell lung cancer
    Exclusion Criteria:
    • the rest of the disease stage

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Medical Research Center of Oncology. N. N. Blokhin Moscow Russian Federation 115478

    Sponsors and Collaborators

    • Autonomous Non-Profit Organization National Society of Onco-Pulmonologists

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Autonomous Non-Profit Organization National Society of Onco-Pulmonologists
    ClinicalTrials.gov Identifier:
    NCT05157503
    Other Study ID Numbers:
    • 4
    First Posted:
    Dec 15, 2021
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Autonomous Non-Profit Organization National Society of Onco-Pulmonologists
    non-small cell lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Dec 15, 2021