Serial Blood Count Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: f
View:

• 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.

Locations
United States
Washington
University of Washington Medical Center - Montlake
RECRUITING
Seattle
Contact Information
Primary
Audrey Anna Bolyard, RN, BSN
bolyard@uw.edu
206-543-7218
Backup
David C. Dale, MD
dcdale@uw.edu
206-543-7215
Time Frame
Start Date: 2024-10-17
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 20
Treatments
Experimental: Serial Blood Count Study
Related Therapeutic Areas
Sponsors
Leads: University of Washington

This content was sourced from clinicaltrials.gov

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