Home blood count monitoring to diagnose cyclic versus severe congenital neutropenia
Official title: Serial Blood Count Study
Run by University of Washington · NCT07066085 · Data updated 2026-11-12
This test uses a home device called Athelas One to measure white blood cell and neutrophil counts in people with known ELANE mutations to see if daily home numbers can diagnose cyclic neutropenia and tell it apart from severe congenital neutropenia.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 5 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | October 17, 2024 |
| Main results expected | December 1, 2025 |
| Study ends | December 1, 2025 |
| Registry record updated | July 15, 2025 |
| Trial ID | NCT07066085 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 5 years or older with confirmed severe chronic neutropenia and a known ELANE mutation who can perform finger-prick sampling and use a smartphone or internet-connected device are ideal candidates.
✕Probably not a fit
Children under 5, people without ELANE mutations, those unable or unwilling to perform home sampling, or those without smartphone/internet access are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study asks participants with confirmed severe chronic neutropenia and a known ELANE mutation to take frequent home white blood cell (WBC) and absolute neutrophil count (ANC) measurements using the Athelas One device. The device has FDA 510(k) clearance for WBC and ANC measurement and data are uploaded via a smartphone app or internet connection. Daily or near-daily home counts over several weeks are used to look for the cyclic pattern of ANC that defines cyclic neutropenia and to distinguish that pattern from the more persistent neutropenia seen in severe congenital neutropenia. Results will be compared with clinical/laboratory data and the participant’s genetic information to judge the device’s diagnostic usefulness.
Why it matters
Potential benefit: If successful, home monitoring could make it much easier and faster to distinguish cyclic neutropenia from severe congenital neutropenia, reducing the need for repeated clinic blood draws and helping guide appropriate treatment decisions such as stem cell transplant referral.
How similar studies have gone: Point-of-care WBC/ANC measurement devices like Athelas One have received FDA clearance and some validation, but using daily home ANC patterns specifically to diagnose cyclic neutropenia is a relatively novel application that is not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of severe chronic neutropenia * 5 years of age or older, male or female * Known positive ELANE mutation * Computer if available * Internet access * Cell phone / Smart phone that can download / install applications (App) * Adults that are comfortable obtaining the samples without medical conditions that would make collection of the sample difficult. Exclusion Criteria: * Diagnosis of severe chronic neutropenia and negative results for the ELANE mutation * Less than 5 years of age * No internet access * No Cell phone or smart phone that cannot download / install applications (App) * Adults that are uncomfortable obtaining the samples or have medical conditions that would make collection of the sample difficult.
Where it's running
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University of Washington Medical Center - Montlake
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: David C. Dale, MD — University of Washington
- Study coordinator: Audrey Anna Bolyard, RN, BSN
- Email: bolyard@uw.edu
- Phone: 206-543-7218
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.