## Protocol Section
### Identification Module
**NCT ID:** NCT06421116

**Acronym:** ORGANOSPA

**Brief Title:** Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis

**Official Title:** Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis

#### Organization Study ID Info
**ID:** 6378
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-07

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-09
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers.

### Conditions Module

**Conditions:**

- Spondyloarthritis

- Inflammatory Bowel Diseases

### Design Module

#### Bio Spec

**Description:** Synovial biopses and intestinal biopses

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Patients will undergo biopsies if needed for standard-of-care follow-up and after clinical indication.

**Name:** Synovial ultrasound-guided biopsy Intestinal biopsy

**Type:** PROCEDURE

### Outcomes Module

#### Other Outcomes

**Description:** Fibroblast-like synoviocytes (FLS) will be dispensed into a well of a Fluorobook invasion plate. The fluorescence will be measured as an index of FLS invasion capacity in the presence of a basement membrane extract.

**Measure:** Invasion capacity assessment (synovial organoids)

**Time Frame:** 24 months

#### Primary Outcomes

**Description:** The viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase.

**Measure:** Viability assessment

**Time Frame:** 24 months

#### Secondary Outcomes

**Description:** The production of cytokines in the culture supernatant of organoids will be evaluated using enzyme-linked immunosorbent assay (ELISA)

**Measure:** Production of pro-inflammatory cytokines

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* More than 18 years of age;
* Ability to understand and sign an informed consent form;
* Clinical indication for intestinal and/or synovial biopsy;
* Only for SpA patients group: meeting ASAS classification criteria.

Exclusion Criteria:

* Actively treated cancer;
* Severe comorbidities that, in the investigator\&#39;s opinion, may affect the quality of samples for planned experimental applications;
* Only for patients undergoing ileal-colic biopsy: history of colorectal cancer disease, celiac disease;
* Only for patients undergoing a synovial biopsy: septic arthritis.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients affected by Spondyloarthtitis. Controls with inflammatory or non-inflammatory conditions.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mariaantoniettadagostino@policlinicogemelli.it

**Name:** Maria Antonietta D'Agostino, Professor

**Phone:** +390630157807

**Role:** CONTACT

**Contact 2:**

**Email:** gerlando.natalello1@guest.policlinicogemelli.it

**Name:** Gerlando Natalello, Dr

**Phone:** +390630157807

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rome

**Contacts:**

***Contact 1:***

- **Email:** mariaantoniettadagostino@policlinicogemelli.it

- **Name:** Maria Antonietta D'Agostino, Professor

- **Phone:** +390630157807

- **Role:** CONTACT

***Contact 2:***

- **Name:** Maria Antonietta D'Agostino, Professor

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Gerlando Natalello, Dr

- **Role:** SUB_INVESTIGATOR

**Country:** Italy

**Facility:** Fondazione Policlinico Universitario A. Gemelli IRCCS

**State:** RM

**Status:** RECRUITING

**Zip:** 00168

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005759

- Term: Gastroenteritis

- ID: D000001850

- Term: Bone Diseases, Infectious

- ID: D000007239

- Term: Infections

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M15961

- Name: Spondylitis

- Relevance: HIGH

- As Found: Spondyloarthritis

- ID: M17917

- Name: Inflammatory Bowel Diseases

- Relevance: HIGH

- As Found: Inflammatory Bowel Disease

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23035

- Name: Spondylarthritis

- Relevance: HIGH

- As Found: Spondyloarthritis

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5129

- Name: Bone Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013166

- Term: Spondylitis

- ID: D000025241

- Term: Spondylarthritis

- ID: D000015212

- Term: Inflammatory Bowel Diseases

### Misc Info Module

- Version Holder: 2024-05-31
