Adaptive and Trained Immunity in the Pathogenesis of IgG4... | NCT06844864

Studies
Adaptive and Trained Immunity in the Pathogenesis of IgG4-Related Disease

NCT06844864

Sponsor

IRCCS San Raffaele

Status

Active, not recruiting

Last Update Posted

Apr 30, 2025Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

IgG4 Related Disease

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022FH5R92	Other Grant/Funding Number	Ministero dell'Università e della Ricerca

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Sep 2025Estimated

Completion Date

Sep 2025Estimated

First Submitted Date

Feb 14, 2025

First Submission Date that Met QC Criteria

Feb 19, 2025

First Posted Date

Feb 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2025

Last Update Posted Date

Apr 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emanuel Della Torre, Principal Investigator, Assistant Professor of Internal Medicine, IRCCS San RaffaelePrincipal Investigator

Lead Sponsor

IRCCS San RaffaeleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Enquire involvement of trained immunity in the pathogenesis of IgG4RD

Detailed Description

Enquire involvement of trained immunity in the pathogenesis of IgG4RD using primary macrophages and co-cultures with patient derived fibroblasts. The investigators will first assess whether macrophages from patients are trained compared to macrophages of healthy controls and then challenge them with IgG from IgG4RD patients to evaluate the functional effects on cultivated fibroblasts.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures	Concentration of collagen Ia (ng/uL) in the supernant of macrophage/fibroblast co-cultures through ELISA assay	7 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients:

Adult subjects > or = 18 years of age
Subjects capable of providing informed consent
Active IgG4-RD based on the IgG4-related disease activity index
Fulfillment of the 2019 ACR/EULAR Classification Criteria for IgG4RD

Healthy Controls:

Adult subjects > or = 18 years of age
Subjects capable of providing informed consent

Exclusion Criteria:

Patients and healthy controls:

Subjects < 18 years of age
Pregnant women
Comorbidities (other ongoing active autoimmune diseases, ongoing cancer, ongoing infections)
Ongoing immunosuppressive therapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with IgG4-related disease and healthy controls

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale San Raffaele		Milan	MI	20132	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000077733	Immunoglobulin G4-Related Disease

Ancestor Terms

ID	Term
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided