Neutropenia AutoimmuneDANCChildrenNCT06547931
Duffy-null Associated Neutrphil Count (DANC) Pediatric Patients
An observational study of Neutropenia Autoimmune, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Neutropenia Autoimmune
- What is being tested?
- Data collection and analysis
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2024to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Child
Study population: Pediatric patients sent to our laboratory for the search for anti-neutrophil antibodies in the suspicion of immune neutropenia
Who may be able to join
- presence of Duffy-null phenotype
Who cannot join
- absence of Duffy-null phenotype
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggioe Policlinico
Milan, 20122
About this study
Official title: 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.
- Conditions
- Neutropenia Autoimmune
- Being tested
- Data collection and analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and analysisOther
Retrospective collection of clinical and laboratory data relating to the definition of the nature of neutropenia
| Study group | Role | What they receive |
|---|---|---|
| Duffy null neutropenic subjects | Pediatric patients sent to our laboratory for anti-neutrophil antibodies evaluation in the suspicion of immune neutropenia Receives: Other: Data collection and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Distribution of mild, moderate and severe neutropenia in DANC children
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start30 Jun 2024
- Primary completion30 Sep 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neutropenia AutoimmuneStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Cattaneo, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547931
- Sponsor's protocol ID
- 0017727
- Acronym
- DANCChildren
- Status last verified
- Mar 2026
- First submitted
- 6 Aug 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be made public anonymously and presented as required in aggregate mode
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.
PubMed 17404350Ortiz 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.
PubMed 26925714Rappoport 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.
PubMed 30592023Merz 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.
PubMed 37285802Bux 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.
PubMed 9414283
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of a Cohort of Duffy-null Associated Neutrophil Count (DANC) Pediatric Patients
- ClinicalTrials.gov ID
- NCT06547931
- Acronym / sponsor ID
- DANCChildren / 0017727
- Conditions
- Neutropenia Autoimmune
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duffy null neutropenic subjects | – | Other: Data collection and analysisPediatric patients sent to our laboratory for anti-neutrophil antibodies evaluation in the suspicion of immune neutropenia |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric patients sent to our laboratory for the search for anti-neutrophil antibodies in the suspicion of immune neutropenia
Key inclusion criteria (1 listed)
- presence of Duffy-null phenotype
Key exclusion criteria (1 listed)
- absence of Duffy-null phenotype
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection and analysisRetrospective collection of clinical and laboratory data relating to the definition of the nature of neutropenia | Other | Duffy null neutropenic subjects |
Primary outcome
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.
1 secondary outcome
Distribution of mild, moderate and severe neutropenia in DANC children
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 17404350Hsieh 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.
- Background: PubMed 26925714Ortiz 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.
- Background: PubMed 30592023Rappoport 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.
- Background: PubMed 37285802Merz 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.
- Background: PubMed 9414283Bux 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.
- Individual participant dataSharing planned: Yes. The data will be made public anonymously and presented as required in aggregate mode
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenia Autoimmune, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune neutropenia and DANC (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547931, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.