## Protocol Section
### Identification Module
**NCT ID:** NCT06413459

**Acronym:** BioMol-MA

**Brief Title:** Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis

**Official Title:** Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis

#### Organization Study ID Info
**ID:** BioMol-MA
#### Organization
**Class:** OTHER
**Full Name:** Ospedale San Raffaele
### Status Module
#### Completion Date
**Date:** 2027-03-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-03-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-04-08

**Type:** ACTUAL

**Status Verified Date:** 2023-09

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

#### Lead Sponsor

**Class:** OTHER

**Name:** Ospedale San Raffaele

#### Responsible Party

**Investigator Affiliation:** Ospedale San Raffaele

**Investigator Full Name:** Nicola Lore

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** In this project the investigators aim to identify new biological markers by characterizing the response/inflammation associated with the development and progression of M. abscessus lung disease in patients suffering from cystic fibrosis with the aim of increasing current knowledge available on the development and progression of lung disease.

**Detailed Description:** Main objective:

Evaluate the correlation between early alterations in the profile of specific cell populations or expression markers or soluble immunity activation proteins, considering in particular the development and progression of M. abscessus lung disease in patients with cystic fibrosis.

Secondary objectives

* Identify cellular expression profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome
* Identify biomarkers or molecular profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome
* Expand pathogenetic knowledge to support disease progression pulmonary disease from M. abscessus in patients with cystic fibrosis and evaluate their ability to predict clinical outcome.
* Describe the reciprocal interactions between cellular and humoral components of the response inflammatory disease during M. abscessus infection with/without M. abscessus lung disease.

### Conditions Module

**Conditions:**

- Non-Tuberculous Mycobacterial Pneumonia

- Cystic Fibrosis Lung

**Keywords:**

- scRNASec

### Design Module

#### Bio Spec

**Description:** PBMCs and Plasma

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Luminex; scRNAsec

**Label:** CF patients with chronic M. abscessus infection

#### Arm Group 2

**Intervention Names:**

- Other: Luminex; scRNAsec

**Label:** CF patients with M. abscessus pulmonary disease

#### Arm Group 3

**Intervention Names:**

- Other: Luminex; scRNAsec

**Label:** CF patients with no history of M. abscessus infection

#### Arm Group 4

**Intervention Names:**

- Other: Luminex; scRNAsec

**Label:** Healty Controls

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CF patients with M. abscessus pulmonary disease

- CF patients with chronic M. abscessus infection

- CF patients with no history of M. abscessus infection

- Healty Controls

**Description:** Evaluation of specific cell populations associated with development of M. abscessus lung disease; evaluation of circulating factors related to immunoresponses

**Name:** Luminex; scRNAsec

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluate the correlation between early alterations in the profile of specific cell populations or expression markers or soluble immunity activation proteins, considering in particular the development and progression of M. abscessus lung disease in patients with cystic fibrosis

**Measure:** profile of specific cell populations and expression markers to determine the development and progression of M. abscessus lung disease in patients with CF

**Time Frame:** One month after enrollment visit

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with a certain diagnosis of cystic fibrosis and visited during normal clinical practice, in accordance with the standard operating procedures in force at the Centres.
* Both sexes
* Age \>18 years
* Obtaining informed consent for patients (based on the procedures established by the protocol).

Exclusion Criteria:

* Patients unable to understand the instructions and information provided and be able to adequately accept the study methods.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with cystic fibrosis

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lore.nicolaivan@hsr.it

**Name:** Nicola I Lorè, PhD

**Phone:** +390226434902

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Milan

**Contacts:**

***Contact 1:***

- **Email:** nicolaivanlore@hsr.it

- **Name:** Nicola I Lorè, PhD

- **Phone:** +390226434902

- **Role:** CONTACT

**Country:** Italy

**Facility:** Ospedale San Raffaele

**State:** MI

**Status:** RECRUITING

**Zip:** 20132

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000007232

- Term: Infant, Newborn, Diseases

- ID: D000017563

- Term: Lung Diseases, Interstitial

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Lung Disease

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Fibrosis

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M6755

- Name: Cystic Fibrosis

- Relevance: HIGH

- As Found: Cystic Fibrosis

- ID: M12119

- Name: Mycobacterium Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20559

- Name: Disease Progression

- Relevance: LOW

- As Found: Unknown

- ID: M14512

- Name: Pulmonary Fibrosis

- Relevance: HIGH

- As Found: Fibrosis Lung

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19813

- Name: Lung Diseases, Interstitial

- Relevance: LOW

- As Found: Unknown

- ID: T1710

- Name: Cystic Fibrosis

- Relevance: HIGH

- As Found: Cystic Fibrosis

- ID: T3976

- Name: Mycobacterium Abscessus

- Relevance: HIGH

- As Found: Mycobacterium Abscessus

### Condition Browse Module - Meshes

- ID: D000003550

- Term: Cystic Fibrosis

- ID: D000008171

- Term: Lung Diseases

- ID: D000011658

- Term: Pulmonary Fibrosis

- ID: D000005355

- Term: Fibrosis

### Misc Info Module

- Version Holder: 2024-05-31
