| NCT ID | NCT07066085 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Washington |
| Condition | Cyclic Neutropenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-10-17 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-10-17 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
David C. Dale, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT07066085 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Cyclic Neutropenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07066085 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07066085 currently recruiting?
Yes, NCT07066085 is actively recruiting participants. Contact the research team at bolyard@uw.edu for enrollment information.
Where is the NCT07066085 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT07066085 clinical trial?
NCT07066085 is sponsored by University of Washington. The principal investigator is David C. Dale, MD at University of Washington. The trial plans to enroll 20 participants.