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ACTIVE NOT RECRUITING
NCT06323447

Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia

Sponsor: Leuko Labs, Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia

Key Details

Gender

All

Age Range

10 Years - Any

Study Type

OBSERVATIONAL

Enrollment

210

Start Date

2025-12-15

Completion Date

2027-06-30

Last Updated

2026-07-31

Healthy Volunteers

Not specified

Interventions

DIAGNOSTIC_TEST

PointCheck

Binary classification of severe neutropenia

Locations (6)

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Norton Healthcare Cancer Center

Louisville, Kentucky, United States

Massachussetts General Hospital

Boston, Massachusetts, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

MDA

Houston, Texas, United States

Hospital Universitario 12 de Octubre

Madrid, Spain