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The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer (RIPMIRLC)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Transbronchial forceps biopsy
Transbronchial forceps biopsy+Transbronchial cryobiopsy
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring cryobiopsy, lung cancer, gut-lung microbiota, immune system

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans
  • Control group - patients without non-small cell lung cancer
  • Written (signed) Informed Consent to participate in the study

Exclusion Criteria:

  • severe hypoxemia (partial pressure of oxygen (pO2)< 60 mmHg) or hypercapnia (carbon dioxide partial pressure (pCO2)> 50 mmHg),
  • bleeding disorders
  • The diffusing capacity for carbon monoxide (DLCOc)< 35 %,
  • forced expiratory volume in one second (FEV1) < 800 ml or FEV 1 < 30 %,
  • peripheral lung tumor was not visualised by RP-EBUS longer than 30 minutes
  • large vessels (more than 3 mm) near the tumor on the CT scan,
  • technically difficult to introduce cryoprobe and/or endobronchial blocker to current bronchi segment or subsegment,
  • excessive bleeding after transbronchial forceps biopsy, which was needed extra intervention to stop bleeding.

Sites / Locations

  • Lithuanian University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transbronchial forceps biopsy

Transbronchial forceps biopsy+Transbronchial cryobiopsy

Arm Description

Patients, whose transbronchial forceps biopsy was performed

Patients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

overall survival

Full Information

First Posted
November 18, 2021
Last Updated
October 3, 2023
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05164445
Brief Title
The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer
Acronym
RIPMIRLC
Official Title
Observational Participants Not Assigned to Intervention(s) Based on a Protocol; Typically in Context of Routine Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate complications, specificity, diagnostic yield of radial endobronchial ultrasound guided transbronchial cryobiopsy and transbronchial forceps biopsy with fluoroscopy in the diagnosis of peripheral pulmonary lesion; the interplay between non-small-cell lung cancer associated-bacteria along the gut-lung axis and immune response in the cancer microenvironment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
cryobiopsy, lung cancer, gut-lung microbiota, immune system

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transbronchial forceps biopsy
Arm Type
Active Comparator
Arm Description
Patients, whose transbronchial forceps biopsy was performed
Arm Title
Transbronchial forceps biopsy+Transbronchial cryobiopsy
Arm Type
Active Comparator
Arm Description
Patients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well
Intervention Type
Diagnostic Test
Intervention Name(s)
Transbronchial forceps biopsy
Intervention Description
All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and mini probe endobronchial ultrasound (RP-EBUS) scans were enrolled. Transbronchial forceps biopsy (TBFB) was performed for all these patients.
Intervention Type
Diagnostic Test
Intervention Name(s)
Transbronchial forceps biopsy+Transbronchial cryobiopsy
Intervention Description
All patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans were enrolled. TBFB was performed for all these patients. In addition, all of these patients, with no contraindications, underwent transbronchial cryobiopsy (TBCB)
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
one year after enrolment to the study
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
3 years after enrolment to the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with peripheral lung lesion suspected of lung cancer detected on the chest computed tomography (CT) and RP-EBUS scans Control group - patients without non-small cell lung cancer Written (signed) Informed Consent to participate in the study Exclusion Criteria: severe hypoxemia (partial pressure of oxygen (pO2)< 60 mmHg) or hypercapnia (carbon dioxide partial pressure (pCO2)> 50 mmHg), bleeding disorders The diffusing capacity for carbon monoxide (DLCOc)< 35 %, forced expiratory volume in one second (FEV1) < 800 ml or FEV 1 < 30 %, peripheral lung tumor was not visualised by RP-EBUS longer than 30 minutes large vessels (more than 3 mm) near the tumor on the CT scan, technically difficult to introduce cryoprobe and/or endobronchial blocker to current bronchi segment or subsegment, excessive bleeding after transbronchial forceps biopsy, which was needed extra intervention to stop bleeding.
Facility Information:
Facility Name
Lithuanian University of Health Sciences
City
Kaunas
ZIP/Postal Code
LT 44307
Country
Lithuania

12. IPD Sharing Statement

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The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer

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