Serial Blood Count Study

NCT ID: NCT07066085

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2025-12-01

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.

Detailed Description

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.

Cyclic neutropenia (CyN) usually occurs as an autosomal dominant disorder caused by mutations in the gene for neutrophil elastase, ELANE. Severe congenital neutropenia (SCN) is also hereditary and caused by mutations in the same gene. Distinguishing between these diseases by genotyping is imprecise because of overlap in the mutational profiles. However, the distinction is critical because SCN has a far greater risk of evolution to myelodysplasia (MDS) and acute myeloid leukemia (AML). The risk is approximately 20-25% for patients with SCN and less than 1% for CyN. Because of this risk, patients with SCN are likely to be referred for hematopoietic stem cell transplantation (HSCT), whereas CyN patients are not. The best way to distinguish between these conditions is with serial ANC determinations. It is not easy for subjects to get 6 weeks of daily blood counts because this requires repeated trips to a clinical laboratory for blood draws, usually from a vein in the arm. From the subject's and family's perspective, the trips are time-consuming and expensive, testing is expensive, and the blood draws often lead to bruising and arm pain from repeated pokes. The goal of the study is to learn if patients will be compliant with use of the fingerstick technique to obtain a blood sample for 6 weeks and see the results of the WBC and ANC results so that clinicians can clearly distinguish between the two conditions.

Conditions

Cyclic Neutropenia; Congenital Neutropenia; Neutropenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Serial Blood Count Study

Group Type: EXPERIMENTAL

Serial Blood Count Study

Intervention Type: 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.

Athelas Home device

Intervention Type: 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.

Interventions

Serial Blood Count Study

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.

Intervention Type: DEVICE

Athelas Home 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

David Dale

Professor, Division of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David C. Dale, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Medical Center - Montlake

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Audrey Anna Bolyard, RN, BSN

Role: CONTACT

bolyard@uw.edu

206-543-7218

David C. Dale, MD

Role: CONTACT

dcdale@uw.edu

206-543-7215

Facility Contacts

David C. Dale, MD

Role: primary

dcdale@uw.edu

206-543-7215

Audrey Anna Bolyard, RN, BSN

Role: backup

bolyard@uw.edu

206-543-7218

Other Identifiers

STUDY00020909

Identifier Type: -

Identifier Source: org_study_id