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

Running, not enrolling

Conditions studied: Diffuse Large B Cell Lymphoma, Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06323447

Run by

Leuko Labs, Inc.

People needed

210

Starts

2025-12-15

Expected to finish

2027-06-30

Last updated by the study team

2026-07-31

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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