NCT06392334

Brief Summary

Mast cells proteases such as chymase and tryptase will be studied in the tissue of small and large airways in COPD patients

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 29, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2019

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

6.6 years

First QC Date

September 22, 2019

Last Update Submit

April 26, 2024

Conditions

COPD Exacerbation

Keywords

mast celltryptasechymaseCOPD

Outcome Measures

Primary Outcomes (1)

  • Number of mast cells in COPD lung tissue

    Assesment of mast cells in lung tissue in COPD patients

    up to 10 -12 months

Study Arms (1)

Biopsy

OTHER

Biopsy of lung tissue will be done

Other: Biopsy

Interventions

BiopsyOTHER

Biopsy of lung tissue

Biopsy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- COPD patients

You may not qualify if:

  • Other lung diseases, tumors, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Voronezh State Medical University

Voronezh, 394019, Russia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Yanina Shkatova

CONTACT

89611875800yankashkat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2019

First Posted

April 30, 2024

Study Start

January 29, 2019

Primary Completion

August 30, 2025

Study Completion

September 30, 2025

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)