NCT05157503

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

3 years

First QC Date

September 21, 2020

Last Update Submit

December 1, 2021

Conditions

Keywords

non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • 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: 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

    10/01/2023

Secondary Outcomes (3)

  • Explore clinical approaches

    10/01/2023

  • Diagnostic algorithm:

    10/01/2023

  • Percentage of treatment options

    10/01/2023

Other Outcomes (1)

  • -Evaluate the frequency of decision-making as a standard practice vs with an individual decision

    10/01/2023

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with morphologically proven stage III non-small cell lung cancer

You may qualify if:

  • \- stage III non-small cell lung cancer

You may not qualify if:

  • \- the rest of the disease stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Medical Research Center of Oncology. N. N. Blokhin

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Konstantin Laktionov, Professor

CONTACT

Valeriy Breder, Leading Researcher

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

December 15, 2021

Study Start

January 10, 2020

Primary Completion

January 15, 2023

Study Completion

March 31, 2023

Last Updated

December 15, 2021

Record last verified: 2021-12

Locations