Cyclic NeutropeniaEarly Phase 1NCT07066085
Serial Blood Count Study
A Early Phase 1 study testing Serial Blood Count Study and Athelas Home device in people with Cyclic Neutropenia and Congenital Neutropenia, run by University of Washington at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Cyclic Neutropenia, Congenital Neutropenia, Neutropenia
- What is being tested?
- Serial Blood Count Study and Athelas Home device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2024to 1 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
David C. Dale, MD, 206-543-7215, dcdale@uw.edu
Audrey Anna Bolyard, RN, BSN, 206-543-7218, bolyard@uw.edu
About this study
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.
Read the 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
- Being tested
- Serial Blood Count Study, Athelas Home device
- Keywords
- Neutropenia, Cyclic Neutropenia, Congenital Neutropenia, Device
- Medical subject headings
- Cyclic neutropenia, Neutropenia, Severe Congenital, Autosomal Recessive 3, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial Blood Count StudyDevice
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 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Serial Blood Count Study | Experimental | Not described Receives: Device: Serial Blood Count Study; Device: Athelas Home device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test feasibility of device for white blood cell (WBC) count
Measured: Daily blood counts over a period of 42 days (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start17 Oct 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclic NeutropeniaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Dale, University of Washington
- Investigators
- David C. Dale, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066085
- Sponsor's protocol ID
- STUDY00020909
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Blood Count Study
- ClinicalTrials.gov ID
- NCT07066085
- Acronym / sponsor ID
- STUDY00020909
- Conditions
- Cyclic Neutropenia, Congenital Neutropenia, Neutropenia
- Keywords
- Neutropenia, Cyclic Neutropenia, Congenital Neutropenia, Device
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serial Blood Count Study | Experimental | Device: Serial Blood Count Study, Device: Athelas Home device |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of severe chronic neutropenia
- 5 years of age or older, male or female
- Known positive ELANE mutation
- Computer if available
- Internet access
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial Blood Count StudyA 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. | Device | Serial Blood Count Study |
| Athelas Home deviceA 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. | Device | Serial Blood Count Study |
Primary outcome
Test feasibility of device for white blood cell (WBC) count
Time frame: Daily blood counts over a period of 42 days (6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David C. Dale, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Serial Blood Count Study and Athelas Home device in people with Cyclic Neutropenia and Congenital Neutropenia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Anna Bolyard, RN, BSN (206-543-7218, bolyard@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test feasibility of device for white blood cell (WBC) count (time frame: Daily blood counts over a period of 42 days (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.