Serial Blood Count Study

NCT07066085 | Recruiting Early Phase 1 FDA Device

• 1 other identifier: STUDY00020909
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cyclic Neutropenia; Congenital Neutropenia; Neutropenia

Keywords

Neutropenia; Cyclic Neutropenia; Congenital Neutropenia; Device

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (1)

Serial Blood Count Study

EXPERIMENTAL

Device: Serial Blood Count Study; Device: Athelas Home device

Interventions

Serial Blood Count Study DEVICE

A new home monitoring device called Athelas One (or Athelas Home) was granted an FDA 510K Class 2 clearance for evaluation of white blood count (WBC) and absolute neutrophil count (ANC). The device uses a drop of blood on a slide to measure the WBC and ANC. The drop of blood is obtained using a lancet that comes with the device, it is just like how diabetics do with a glucose monitoring device. The process will be done once a day for 42 days (6 weeks) unless the drop is not placed on the slide correctly. If there is an issue with the first attempt, the process could be done again to obtain the WBC and ANC results. The Athelas device is intended for use by patients with neutropenia or patients at risk of neutropenia. The device is indicated for use by patients and caregivers within home settings with results viewable by health care professionals.

Serial Blood Count Study

Athelas Home device DEVICE

A new home monitoring device called Athelas One (or Athelas Home) was granted an FDA 510K Class 2 clearance for evaluation of white blood count (WBC) and absolute neutrophil count (ANC). The device uses a drop of blood on a slide to measure the WBC and ANC. The drop of blood is obtained using a lancet that comes with the device, it is just like how diabetics do with a glucose monitoring device. The process will be done once a day for 42 days (6 weeks) unless the drop is not placed on the slide correctly. If there is an issue with the first attempt, the process could be done again to obtain the WBC and ANC results. The Athelas device is intended for use by patients with neutropenia or patients at risk of neutropenia. The device is indicated for use by patients and caregivers within home settings with results viewable by health care professionals.

Serial Blood Count Study

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of severe chronic neutropenia
• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Cyclic neutropenia; Neutropenia, Severe Congenital, Autosomal Recessive 3; Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• David C. Dale, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey Anna Bolyard, RN, BSN

CONTACT

206-543-7218; bolyard@uw.edu

David C. Dale, MD

CONTACT

206-543-7215; dcdale@uw.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Internal Medicine

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 15, 2025
• Study Start: October 17, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)