The Use of Machine Learning Techniques for the Differenti... | NCT07275190

Studies
The Use of Machine Learning Techniques for the Differential Diagnosis Between Eosinophilic Granulomatosis With Polyangiitis and Hypereosinophilic Syndrome

NCT07275190

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Status

Recruiting

Last Update Posted

Dec 10, 2025Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

EGPA - Eosinophilic Granulomatosis With Polyangiitis
HES - Hypereosinophilic Syndrome

Interventions

Blood draw for the laboratory assessment

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

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Nov 28, 2025

First Submission Date that Met QC Criteria

Nov 28, 2025

First Posted Date

Dec 10, 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

Nov 28, 2025

Last Update Posted Date

Dec 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlomaurizio Montecucco, MD, Fondazione IRCCS Policlinico San Matteo di PaviaPrincipal Investigator

Lead Sponsor

Fondazione IRCCS Policlinico San Matteo di PaviaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to collect clinical, laboratory, and instrumental data from patients with eosinophilic granulomatosis with polyangiitis or hypereosinophilic syndrome, which will then be analyzed using artificial intelligence techniques with the aim of identifying characteristics that differentiate the two diseases and can predict the response to the treatment plan.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood draw for the laboratory assessment	Procedure	Blood draw for the laboratory assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
characteristics that are different between HES and EGPA		18months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or over
A diagnosis of EGPA or HES
Willing and able to give informed written consent, or willing to give permission for a nominated friend or relative to provide written informed assent if they are unable to do so because of physical disabilities

Exclusion Criteria:

Lack of a confirmed diagnosis of EGPA or HES.
Other causes of eosinophilia

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carlomaurizio Montecucco	Contact	390382502948		carlomaurizio.montecucco@unipv.it
Alessandra Milanesi	Contact	0382502498		al.milanesi@smatteo.pv.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione IRCCS Policlinico San Matteo, SC Reumatologia	Recruiting	Pavia		27100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D015267	Churg-Strauss Syndrome
D017681	Hypereosinophilic Syndrome

Ancestor Terms

ID	Term
D056648	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
D056647	Systemic Vasculitis
D014657	Vasculitis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006099	Granuloma
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D004802	Eosinophilia
D007960	Leukocyte Disorders
D006402	Hematologic Diseases

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D011677	Punctures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques