RecruitingEarly Phase 1

Serial Blood Count Study

United States20 participantsStarted 2024-10-17

Plain-language summary

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.

Who can participate

Age range5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Test feasibility of device for white blood cell (WBC) count

Timeframe: Daily blood counts over a period of 42 days (6 weeks)

Trial details

NCT IDNCT07066085

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

Contact for this trial

Audrey Anna Bolyard, RN, BSN

206-543-7218 bolyard@uw.edu