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

October 3, 2023 updated by: Marius Zemaitis, Lithuanian University of Health Sciences

Observational Participants Not Assigned to Intervention(s) Based on a Protocol; Typically in Context of Routine Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Kaunas, Lithuania, LT 44307
        • Lithuanian University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transbronchial forceps biopsy
Patients, whose transbronchial forceps biopsy was performed
Diagnostic test: Transbronchial forceps biopsy
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.
Active Comparator: Transbronchial forceps biopsy+Transbronchial cryobiopsy
Patients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well
Diagnostic test: Transbronchial forceps biopsy+Transbronchial cryobiopsy
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: one year after enrolment to the study
one year after enrolment to the study

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 years after enrolment to the study
3 years after enrolment to the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPMIRLC-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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