## Protocol Section
### Identification Module
**NCT ID:** NCT02235779

**Brief Title:** Diagnostic Yield of Transbronchial Cryobiopsy in Diagnosis of Interstitial Lung Diseases

**Official Title:** DIagnostic Yield of Transbronchial Cryobiopsies in Subjects With Interstitial Lung Disease

#### Organization Study ID Info
**ID:** CryobiopsieTBB
#### Organization
**Class:** OTHER
**Full Name:** Laval University
### Status Module
#### Completion Date
**Date:** 2021-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-03-08

**Type:** ACTUAL

**Last Update Submit Date:** 2021-03-04

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-08

**Status Verified Date:** 2021-03

#### Study First Post Date
**Date:** 2014-09-10
**Type:** ESTIMATED
**Study First Submit Date:** 2014-08-26
**Study First Submit QC Date:** 2014-09-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Laval University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** See above

### Conditions Module

**Conditions:**

- Interstitial Lung Disease

**Keywords:**

- ILD

- Pulmonary fibrosis

- Cryobiopsy

- Transbronchial

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Transbronchial lung cryobiopsy

**Label:** Cryobiopsy

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cryobiopsy

**Name:** Transbronchial lung cryobiopsy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Overall diagnostic yield of cryobiopsy specimens in interstitial lung disease

**Time Frame:** After biopsy (up to 24 months)

#### Secondary Outcomes

**Description:** Assessment of complications related to cryoTBB:

* pneumothorax
* hemorrage
* other complications

**Measure:** Complication rate of transbronchial cryobiopsy procedure

**Time Frame:** Per-procedure and up to 24 hours after

**Description:** Diagnostic concordance between cryobiopsy specimen analysis and corresponding surgical lung biopsy done in same subjects (same lung/lobe)

**Measure:** Number of diagnostic specimens of cryoTBB in comparison with surgical lung biopsy specimen

**Time Frame:** After biopsy (up to 24 months)

**Description:** Interobserver agreement rate between two different pathologists blinded to subject history/radiological record and surgical lung biopsy specimen.

**Measure:** Inter-observer agreement for cryobiopsy specimens

**Time Frame:** After biopsy (up to 24 months)

**Description:** Size of TBB cryobiopsy specimen measured by two different pathologists responsible for its interpretation.

**Measure:** Size of cryobiopsy specimen

**Time Frame:** After biopsy (up to 24months)

**Description:** Pathological quality score of TBB cryobiopsy specimens (artefacts, size, etc.) as assessed by two different pathologists responsible for their interpretation.

**Measure:** Quality of cyrobiopsy specimens

**Time Frame:** After biopsy (up to 24 months)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** antoine.delage@criucpq.ulaval.ca

**Name:** Antoine Delage, MDCM

**Phone:** 418-656-4747

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Québec

**Contacts:**

***Contact 1:***

- **Email:** antoine.delage@criucpq.ulaval.ca

- **Name:** Antoine Delage, MDCM

- **Phone:** 418-656-4747

- **Role:** CONTACT

***Contact 2:***

- **Name:** Antoine Delage, MDCM

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Simon Martel, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Steeve Provencher, MD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Genevieve Dion, MD

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Philippe Joubert, MD

- **Role:** SUB_INVESTIGATOR

***Contact 7:***

- **Name:** Massimo Conti, MD

- **Role:** SUB_INVESTIGATOR

***Contact 8:***

- **Name:** Paula Ugalde, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Canada

**Facility:** Institut universitaire de cardiologie et de pneumologie de Québec

**Status:** RECRUITING

**Zip:** G1V 4G5

#### Overall Officials

**Official 1:**

**Affiliation:** Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

**Name:** Antoine Delage, MDCM

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Lung Disease

- ID: M14512

- Name: Pulmonary Fibrosis

- Relevance: LOW

- As Found: Unknown

- ID: M19813

- Name: Lung Diseases, Interstitial

- Relevance: HIGH

- As Found: Interstitial Lung Disease

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000017563

- Term: Lung Diseases, Interstitial

### Misc Info Module

- Version Holder: 2024-05-24
