RECRUITING

Serial Blood Count Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Serial Blood Count Study

Quick Facts

Study Start:2024-10-17
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07066085

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of severe chronic neutropenia
  2. * 5 years of age or older, male or female
  3. * Known positive ELANE mutation
  4. * Computer if available
  5. * Internet access
  6. * Cell phone / Smart phone that can download / install applications (App)
  7. * Adults that are comfortable obtaining the samples without medical conditions that would make collection of the sample difficult.
  1. * Diagnosis of severe chronic neutropenia and negative results for the ELANE mutation
  2. * Less than 5 years of age
  3. * No internet access
  4. * No Cell phone or smart phone that cannot download / install applications (App)
  5. * Adults that are uncomfortable obtaining the samples or have medical conditions that would make collection of the sample difficult.

Contacts and Locations

Study Contact

Audrey Anna Bolyard, RN, BSN
CONTACT
206-543-7218
bolyard@uw.edu
David C. Dale, MD
CONTACT
206-543-7215
dcdale@uw.edu

Principal Investigator

David C. Dale, MD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington Medical Center - Montlake
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Washington

  • David C. Dale, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-17
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-10-17
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Neutropenia
  • Cyclic Neutropenia
  • Congenital Neutropenia
  • Device

Additional Relevant MeSH Terms

  • Cyclic Neutropenia
  • Congenital Neutropenia
  • Neutropenia