Interstitial Lung DiseaseNCT02235779
Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases
A study testing Transbronchial lung cryobiopsy in people with Interstitial Lung Disease, run by Laval University at 1 site in Canada.
Trial summary
Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies done via bronchoscopy in the investigation of interstitial lung disease in comparison with videothoracoscopy-assisted surgical lung biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Transbronchial lung cryobiopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer subjects with interstitial lung disease in whom a surgical lung biopsy is planned for diagnostic investigation.
Who cannot join
- Aged less than 18 y.o.
- Pregnancy
- Known coagulatoin disorder or blood dyscrasia
- Aaking antiplatelet agents other than aspirin or therapeutic anticoagulants drugs that cannot be safely discontinued to undergo lung biopsy
- Arterial oxgen pressure less than 60 mmHg on more than 2 liters per minute oxygen
- Known pulmonary hypertension defined as systolic PAP above 40 mmHg on echocardiography
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
Antoine Delage, MDCM, 418-656-4747, antoine.delage@criucpq.ulaval.ca
Antoine Delage, MDCM
About this study
Official title: DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease
Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies done via bronchoscopy in the investigation of interstitial lung disease in comparison with videothoracoscopy-assisted surgical lung biopsy.
Read the detailed description
See above
- Conditions
- Interstitial Lung Disease
- Being tested
- Transbronchial lung cryobiopsy
- Keywords
- ILD, Pulmonary fibrosis, Cryobiopsy, Transbronchial
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transbronchial lung cryobiopsyOther
| Study group | Role | What they receive |
|---|---|---|
| Cryobiopsy | Other | Not described Receives: Other: Transbronchial lung cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease
Number of cryobiopsy specimens from which a specific diagnosis of interstitial lung disease can be ascertained, as assessed by a two different pathologists blinded to the known final diagnosis.
Measured: After biopsy (up to 24 months)
Secondary outcomes (5)
Complication rate of transbronchial cryobiopsy procedure
Assessment of complications related to cryoTBB:
- pneumothorax
- hemorrage
- other complications
Measured: Per-procedure and up to 24 hours after
Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen
Diagnostic concordance between cryobiopsy specimen analysis and corresponding surgical lung biopsy done in same subjects (same lung/lobe)
Measured: After biopsy (up to 24 months)
Inter-observer agreement for cryobiopsy specimens
Interobserver agreement rate between two different pathologists blinded to subject history/radiological record and surgical lung biopsy specimen.
Measured: After biopsy (up to 24 months)
Size of cryobiopsy specimen
Size of TBB cryobiopsy specimen measured by two different pathologists responsible for its interpretation.
Measured: After biopsy (up to 24months)
Quality of cyrobiopsy specimens
Pathological quality score of TBB cryobiopsy specimens (artefacts, size, etc.) as assessed by two different pathologists responsible for their interpretation.
Measured: After biopsy (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Delage, MDCM, Study chair, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235779
- Sponsor's protocol ID
- CryobiopsieTBB
- Status last verified
- Mar 2021
- First submitted
- 26 Aug 2014
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Fortin M, Liberman M, Delage A, Dion G, Martel S, Rolland F, Soumagne T, Trahan S, Assayag D, Albert E, Kelly MM, Johannson KA, Guenther Z, Leduc C, Manganas H, Prenovault J, Provencher S. Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy: A Prospective Multi-Centre Agreement Clinical Trial (CAN-ICE). Am J Respir Crit Care Med. 2023 Jun 15;207(12):1612-1619. doi: 10.1164/rccm.202209-1812OC.
PubMed 36796092
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02235779
- Acronym / sponsor ID
- CryobiopsieTBB
- Conditions
- Interstitial Lung Disease
- Keywords
- ILD, Pulmonary fibrosis, Cryobiopsy, Transbronchial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 10 Sep 2014 (estimated)
- 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.
Evaluation of diagnostic yield, feasibility and safety of transbronchial lung cryobiopsies done via bronchoscopy in the investigation of interstitial lung disease in comparison with videothoracoscopy-assisted surgical lung biopsy.
Detailed description
See above
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryobiopsy | Other | Other: Transbronchial lung cryobiopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteer subjects with interstitial lung disease in whom a surgical lung biopsy is planned for diagnostic investigation.
Key exclusion criteria (7 listed)
- Aged less than 18 y.o.
- Pregnancy
- Known coagulatoin disorder or blood dyscrasia
- Aaking antiplatelet agents other than aspirin or therapeutic anticoagulants drugs that cannot be safely discontinued to undergo lung biopsy
- Arterial oxgen pressure less than 60 mmHg on more than 2 liters per minute oxygen
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 lung cryobiopsy | Other | Cryobiopsy |
Primary outcome
Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease
Time frame: After biopsy (up to 24 months)
Number of cryobiopsy specimens from which a specific diagnosis of interstitial lung disease can be ascertained, as assessed by a two different pathologists blinded to the known final diagnosis.
5 secondary outcomes
Complication rate of transbronchial cryobiopsy procedure
Time frame: Per-procedure and up to 24 hours after
Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen
Time frame: After biopsy (up to 24 months)
Inter-observer agreement for cryobiopsy specimens
Time frame: After biopsy (up to 24 months)
Size of cryobiopsy specimen
Time frame: After biopsy (up to 24months)
Quality of cyrobiopsy specimens
Time frame: After biopsy (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 36796092Fortin M, Liberman M, Delage A, Dion G, Martel S, Rolland F, Soumagne T, Trahan S, Assayag D, Albert E, Kelly MM, Johannson KA, Guenther Z, Leduc C, Manganas H, Prenovault J, Provencher S. Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy: A Prospective Multi-Centre Agreement Clinical Trial (CAN-ICE). Am J Respir Crit Care Med. 2023 Jun 15;207(12):1612-1619. doi: 10.1164/rccm.202209-1812OC.
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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.
Antoine Delage, MDCM study chair
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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 lung cryobiopsy in people with Interstitial Lung Disease, run by Laval University at 1 site in Canada.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Mar 2021. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine Delage, MDCM (418-656-4747, antoine.delage@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease (time frame: After biopsy (up to 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02235779, which also lists 1 linked publication.
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 8 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.