## Protocol Section
### Identification Module
**NCT ID:** NCT04187079

**Brief Title:** Immunopathologic Profiles and Blood Biomarkers in Patients With IPF

**Official Title:** Immunopathologic Profiles of the Lung Micro- Environment Using Cryobiopsies and Identification of Blood Biomarkers in Patients With IPF

#### Organization Study ID Info
**ID:** Cryobiopsy in IPF
#### Organization
**Class:** OTHER
**Full Name:** University of Aarhus
### Status Module
#### Completion Date
**Date:** 2021-07-27

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-08-10

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2017-09-18

**Type:** ACTUAL

**Status Verified Date:** 2021-07

#### Study First Post Date
**Date:** 2019-12-05
**Type:** ACTUAL
**Study First Submit Date:** 2019-12-02
**Study First Submit QC Date:** 2019-12-02
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Aarhus University Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Aarhus

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Examination of expression of PD-L1, PD-L2, Beta- catenin, B-cell follicles and Tenascin- C in patients with IPF compared with other interstitial lung diseases. Examination of anti HSP 70, p-ANCA, c-ANCA, CD4+/CD28- and CD8+/CD28- cells in patients with IPF compared with other interstitial lung diseases.

Compare the above mentioned findings with changes in pulmonary function tests, 6 minute walking test, exacerbation and mortality over a 2 year follow-up period.

**Detailed Description:** Examination of expression of PD-L1, PD-L2, Beta- catenin, B-cell follicles and Tenascin- C in cryobiopsies from the lungs inpatients with IPF compared with other interstitial lung diseases. Examination of anti HSP 70, p-ANCA, c-ANCA, CD4+/CD28- and CD8+/CD28- cells in blood samples in patients with IPF compared with other interstitial lung diseases.

Compare the above mentioned findings with changes in pulmonary function tests, 6 minute walking test, exacerbation and mortality over a 2 year follow-up period.

### Conditions Module

**Conditions:**

- Idiopathic Pulmonary Fibrosis

### Design Module

#### Bio Spec

**Description:** Plasma Cryobiopsies

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients diagnosed with idiopathic pulmonary fibrosis after multidisciplinary team discussion using medical history, HRCT pattern, laboratory findings, pulmonary function tests and cryobiopsy specimens.

**Label:** IPF

#### Arm Group 2

**Description:** Patients diagnosed with other interstitial diseases other than IPF after multidisciplinary team discussion using medical history, HRCT pattern, laboratory findings, pulmonary function tests and cryobiopsy specimens.

**Label:** Other ILDs

### Outcomes Module

#### Primary Outcomes

**Description:** Expression of PD-L1 in the epithelial cells in lungs

**Measure:** PD-L1

**Time Frame:** At diagnosis

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients suspected of having an ILD who are having cryobiopsies performed

Exclusion Criteria:

* BMI \> 35
* DLCO \< 35%
* FVC \< 45%
* Pulmonary hypertension
* Cardiac or other severe comorbidity that will increase the risk of complications

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients suspected of having an ILD who are having cryobiopsies performed to get a histological specimen for the diagnoses.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aarhus

**Country:** Denmark

**Facility:** Aarhus University Hospital, Department of Respiratory Diseases and Allergy

**Zip:** 8000

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Respiratory Diaseses, Aarhus University Hospital

**Name:** Venerino Poletti, Prof

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005355

- Term: Fibrosis

- ID: D000010335

- Term: Pathologic Processes

- ID: D000017563

- Term: Lung Diseases, Interstitial

- ID: D000008171

- Term: Lung Diseases

- 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

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

- ID: M14512

- Name: Pulmonary Fibrosis

- Relevance: HIGH

- As Found: Pulmonary Fibrosis

- ID: M27989

- Name: Idiopathic Pulmonary Fibrosis

- Relevance: HIGH

- As Found: Idiopathic Pulmonary Fibrosis

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19813

- Name: Lung Diseases, Interstitial

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3003

- Name: Idiopathic Pulmonary Fibrosis

- Relevance: HIGH

- As Found: Idiopathic Pulmonary Fibrosis

### Condition Browse Module - Meshes

- ID: D000011658

- Term: Pulmonary Fibrosis

- ID: D000054990

- Term: Idiopathic Pulmonary Fibrosis

### Misc Info Module

- Version Holder: 2024-05-24
