Serial Blood Count Study
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age5+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
Qualifiers
Confirmed diagnosis of severe chronic neutropenia
5 years of age or older, male or female
Known positive ELANE mutation
Computer if available
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Serial Blood Count Study
- Athelas Home device
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov