🏛️ Verified NIH Record • Updated 2026-07-30
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia (NCT06323447)
Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Leuko Labs, Inc.
🩺 Plain-English Summary (8th-Grade Level)
Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.
Who can join: Review the eligibility criteria below.
Location: University of Hawaii Cancer Center — Honolulu, Hawaii
Age range: 10 Years
🧪 Interventions in This Study
- PointCheck (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- University of Hawaii Cancer Center — Honolulu, Hawaii
- Norton Healthcare Cancer Center — Louisville, Kentucky
- Massachussetts General Hospital — Boston, Massachusetts
- Hackensack University Medical Center — Hackensack, New Jersey
- MDA — Houston, Texas
- Hospital Universitario 12 de Octubre — Madrid,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.