Duffy-null Associated Neutrphil Count (DANC) Pediatric Patients

NCT06547931 | Completed

• 1 other identifier: 0017727
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutropenia Autoimmune

Outcome Measures

Primary Outcomes (1)

• Immune neutropenia and DANC

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Distribution of mild, moderate and severe neutropenia in DANC children

  Through study completion, an average of 1 year

Other Outcomes (1)

• Neutropenia severity and infections

  Through study completion, an average of 1 year

Study Arms (1)

Duffy null neutropenic subjects

Pediatric patients sent to our laboratory for anti-neutrophil antibodies evaluation in the suspicion of immune neutropenia

Other: Data collection and analysis

Interventions

Data collection and analysis OTHER

Retrospective collection of clinical and laboratory data relating to the definition of the nature of neutropenia

Duffy null neutropenic subjects

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients sent to our laboratory for the search for anti-neutrophil antibodies in the suspicion of immune neutropenia

You may qualify if:

• presence of Duffy-null phenotype

You may not qualify if:

• absence of Duffy-null phenotype

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggioe Policlinico

Milan, 20122, Italy

Location

Related Publications (5)

• Hsieh MM, Everhart JE, Byrd-Holt DD, Tisdale JF, Rodgers GP. Prevalence of neutropenia in the U.S. population: age, sex, smoking status, and ethnic differences. Ann Intern Med. 2007 Apr 3;146(7):486-92. doi: 10.7326/0003-4819-146-7-200704030-00004.

  PMID: 17404350 BACKGROUND

• Ortiz MV, Meier ER, Hsieh MM. Identification and Clinical Characterization of Children With Benign Ethnic Neutropenia. J Pediatr Hematol Oncol. 2016 Apr;38(3):e140-3. doi: 10.1097/MPH.0000000000000528.

  PMID: 26925714 BACKGROUND

• Rappoport N, Simon AJ, Amariglio N, Rechavi G. The Duffy antigen receptor for chemokines, ACKR1,- 'Jeanne DARC' of benign neutropenia. Br J Haematol. 2019 Feb;184(4):497-507. doi: 10.1111/bjh.15730. Epub 2018 Dec 27.

  PMID: 30592023 BACKGROUND

• Merz LE, Li SH, Ney G, Michniacki TF, Hannibal MC, Walkovich KJ. Absolute neutrophil count nadir in healthy pediatric patients with the Duffy-null phenotype. Blood Adv. 2023 Aug 8;7(15):4182-4185. doi: 10.1182/bloodadvances.2023010368. No abstract available.

  PMID: 37285802 BACKGROUND

• Bux J, Behrens G, Jaeger G, Welte K. Diagnosis and clinical course of autoimmune neutropenia in infancy: analysis of 240 cases. Blood. 1998 Jan 1;91(1):181-6.

  PMID: 9414283 BACKGROUND

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biologist

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: June 30, 2024
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication

Locations

IT (1)