Duffy-null Associated Neutrphil Count (DANC) Pediatric Patients (DANCChildren)
March 23, 2026 updated by: Alessandra Cattaneo, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Retrospective Analysis of a Cohort of Duffy-null Associated Neutrophil Count (DANC) Pediatric Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Milan, Italy, 20122
- Fondazione IRCCS Ca' Granda Ospedale Maggioe Policlinico
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
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
Description
Inclusion Criteria:
- presence of Duffy-null phenotype
Exclusion Criteria:
- absence of Duffy-null phenotype
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Duffy null neutropenic subjects
Pediatric patients sent to our laboratory for anti-neutrophil antibodies evaluation in the suspicion of immune neutropenia
|
Retrospective collection of clinical and laboratory data relating to the definition of the nature of neutropenia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Immune neutropenia and DANC
Time Frame: 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.
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distribution of mild, moderate and severe neutropenia in DANC children
Time Frame: 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
|
Through study completion, an average of 1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neutropenia severity and infections
Time Frame: Through study completion, an average of 1 year
|
Correlation between the severity of neutropenia and the presence of infections.
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2024
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
November 30, 2025
Study Registration Dates
First Submitted
August 6, 2024
First Submitted That Met QC Criteria
August 8, 2024
First Posted (Actual)
August 9, 2024
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 23, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0017727
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data will be made public anonymously and presented as required in aggregate mode
IPD Sharing Time Frame
Starting 6 months after publication
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.