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Serial Blood Count Study

RecruitingEarly phase 1

Who can join

Ages 5 and older · All sexes

Full eligibility 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.

About the study

The objective of the Serial Blood Count Study is to determine the utility of home monitoring of white blood cell (WBC) and absolute neutrophil counts (ANC) to diagnose cyclic neutropenia and distinguish between cyclic and severe congenital neutropenia (SCN). A new home monitoring device called Athelas One was granted an FDA 510K Class 2 clearance for evaluation of white blood count (WBC) and absolute neutrophil count (ANC). The investigators believe this device provides a unique and extremely valuable opportunity to for diagnosis of these diseases.

What is being tested

Sponsor: University of Washington · Participants: 20 · Started: Oct 17, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT07066085

Locations in the U.S.

WashingtonUniversity of Washington Medical Center - Montlake, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.