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Recruiting Observational

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

NCT06323447 · tracked via the Priya Life Science USA tracker
Sponsor
Leuko Labs, Inc
Phase
Observational
Started
2025-12-15
Last updated
2026-11-03

Condition(s) studied

Diffuse Large B Cell LymphomaMultiple Myeloma

Investigational drug(s) / intervention(s)

PointCheck

PointCheck: Binary classification of severe neutropenia

Study 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.

Eligibility

Sex
ALL
Min age
10 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. * Male or Female aged 10 years or above. * Diagnosed with either Diffuse Large B Cell Lymphoma or Multiple Myeloma. * Scheduled treatment with any antineoplastic therapy with an associated high/intermediate risk of neutropenia according to NCCN guidelines. * Able (in the investigator's opinion) and willing to comply with all study requirements. Exclusion Criteria: * Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator. * Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold. * Participants with circulating tumour cells in previous or current lab determinations. * Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor). * Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg). * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Primary outcome measure(s)

  • PointCheck Accuracy — Two weeks
    The main primary endpoints for this study will be the sensitivity and specificity of PointCheckTM to detect grade IV neutropenia ac cording to the CTCAE V5 definition of severe neutropenia in a standard blood analysis.

Trial sites (6)

FacilityCityRegionStatus
University of Hawaii Cancer Center Honolulu Hawaii Recruiting
Norton Healthcare Cancer Center Louisville Kentucky Recruiting
Massachussetts General Hospital Boston Massachusetts Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
MDA Houston Texas Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06323447 on ClinicalTrials.gov ↗ ← All trials in the USA