Serial Blood Count Study

Recruiting now · Early Phase 1

Conditions studied: Cyclic Neutropenia, Congenital Neutropenia, Neutropenia

In brief

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.

Key facts

Study ID

NCT07066085

Run by

University of Washington

People needed

20

Starts

2024-10-17

Expected to finish

2025-12-01

Last updated by the study team

2025-07-15

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• University of Washington Medical Center - Montlake — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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