NCT02235779

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

7.3 years

First QC Date

August 26, 2014

Last Update Submit

March 4, 2021

Conditions

Interstitial Lung Disease

Keywords

ILDPulmonary fibrosisCryobiopsyTransbronchial

Outcome Measures

Primary Outcomes (1)

  • 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.

    After biopsy (up to 24 months)

Secondary Outcomes (5)

  • Complication rate of transbronchial cryobiopsy procedure

    Per-procedure and up to 24 hours after

  • Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen

    After biopsy (up to 24 months)

  • Inter-observer agreement for cryobiopsy specimens

    After biopsy (up to 24 months)

  • Size of cryobiopsy specimen

    After biopsy (up to 24months)

  • Quality of cyrobiopsy specimens

    After biopsy (up to 24 months)

Study Arms (1)

Cryobiopsy

OTHER
Other: Transbronchial lung cryobiopsy

Interventions

Transbronchial lung cryobiopsyOTHER
Cryobiopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer subjects with interstitial lung disease in whom a surgical lung biopsy is planned for diagnostic investigation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36796092DERIVED

MeSH Terms

Conditions

Lung Diseases, InterstitialPulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antoine Delage, MDCM

    Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    STUDY CHAIR

Central Study Contacts

Antoine Delage, MDCM

CONTACT

418-656-4747antoine.delage@criucpq.ulaval.ca

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

August 26, 2014

First Posted

September 10, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 8, 2021

Record last verified: 2021-03

Locations

CA(1)