Duffy-null Associated Neutrphil Count (DANC) Pediatric Patients

Recruiting

• Conditions: Neutropenia Autoimmune
• Interventions: Other: Data collection and analysis

• Registration Number: NCT06547931
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary

There are currently no clinical and laboratory data that well characterize this neutropenia associated with the Duffy-null phenotype, particularly for pediatric subjects. In particular there are no data on the frequency of immune neutropenia in DANC neutropenic pediatric subjects.

The goal of this study is to :

* define the frequency of immune neutropenia within the cohort of DANC subjects under study

* evaluate the frequency of different degrees of neutropenia (mild-moderate-severe);

* evaluate the possible association between different degrees of neutropenia and the presence of infections.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-30
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• presence of Duffy-null phenotype

Exclusion Criteria

• absence of Duffy-null phenotype

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Duffy null neutropenic subjects	Data collection and analysis	Pediatric patients sent to our laboratory for anti-neutrophil antibodies evaluation in the suspicion of immune neutropenia

Primary Outcome Measures

Name	Time	Method
Immune neutropenia and DANC	Through study completion, an average of 1 year	Frequency of immune neutropenia, expressed as the percentage of DANC subjects testing positive for anti-neutrophil antibodies out of the total DANC subjects included in the study.

Secondary Outcome Measures

Name	Time	Method
Distribution of mild, moderate and severe neutropenia in DANC children	Through study completion, an average of 1 year	Frequencies in percentage of mild (1000-1500 neutrophils/ul), moderate (500-1000 neutrophils/ul) and severe (\<500 neutrophils/ul) neutropenia within the DANC cohort under study

Trial Locations

Locations (1)

Fondazione IRCCS Ca' Granda Ospedale Maggioe Policlinico; 🇮🇹 Milano, Italy