Lung CancerRIPMIRLCNCT05164445
The Role of Interventional Pulmonology, Microbiota and Immune Response in the Patient With Lung Cancer
A study testing Transbronchial forceps biopsy and Transbronchial forceps biopsy+Transbronchial cryobiopsy in people with Lung Cancer, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Transbronchial forceps biopsy and Transbronchial forceps biopsy+Transbronchial cryobiopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Sep 2019to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lung Cancer
- Being tested
- Transbronchial forceps biopsy, Transbronchial forceps biopsy+Transbronchial cryobiopsy
- Keywords
- cryobiopsy, lung cancer, gut-lung microbiota, immune system
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial forceps biopsyDiagnostic test
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.
Transbronchial forceps biopsy+Transbronchial cryobiopsyDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| Transbronchial forceps biopsy | Active comparator | Patients, whose transbronchial forceps biopsy was performed Receives: Diagnostic Test: Transbronchial forceps biopsy |
| Transbronchial forceps biopsy+Transbronchial cryobiopsy | Active comparator | Patients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well Receives: Diagnostic Test: Transbronchial forceps biopsy+Transbronchial cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: one year after enrolment to the study
Secondary outcomes (1)
overall survival
Measured: 3 years after enrolment to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Sep 2019
- Primary completion1 Feb 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Zemaitis, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164445
- Sponsor's protocol ID
- RIPMIRLC-001
- Acronym
- RIPMIRLC
- Status last verified
- Oct 2023
- First submitted
- 18 Nov 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Participants Not Assigned to Intervention(s) Based on a Protocol; Typically in Context of Routine Care
- ClinicalTrials.gov ID
- NCT05164445
- Acronym / sponsor ID
- RIPMIRLC / RIPMIRLC-001
- Conditions
- Lung Cancer
- Keywords
- cryobiopsy, lung cancer, gut-lung microbiota, immune system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transbronchial forceps biopsy | Active comparator | Diagnostic Test: Transbronchial forceps biopsyPatients, whose transbronchial forceps biopsy was performed |
| Transbronchial forceps biopsy+Transbronchial cryobiopsy | Active comparator | Diagnostic Test: Transbronchial forceps biopsy+Transbronchial cryobiopsyPatients, whose transbronchial forceps biopsy and transbronchial cryobiopsy were performed as well |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transbronchial forceps biopsyAll 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. | Diagnostic test | Transbronchial forceps biopsy |
| Transbronchial forceps biopsy+Transbronchial cryobiopsyAll 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) | Diagnostic test | Transbronchial forceps biopsy+Transbronchial cryobiopsy |
Primary outcome
progression-free survival
Time frame: one year after enrolment to the study
1 secondary outcome
overall survival
Time frame: 3 years after enrolment to the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transbronchial forceps biopsy and Transbronchial forceps biopsy+Transbronchial cryobiopsy in people with Lung Cancer, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: one year after enrolment to the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.