Non-Invasive Detection of Severe Neutropenia in Cancer Patients on High-Risk Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the diagnostic performance of PointCheck, a non-invasive device, in identifying severe neutropenia among adults and adolescents with diffuse large B-cell lymphoma or multiple myeloma who are scheduled for antineoplastic therapy with intermediate to high neutropenia risk. The study uses PointCheck alongside standard clinical assessments to determine its accuracy in detecting neutropenia early. Participants provide informed consent and undergo serial assessments as part of routine care. The trial is led by Leuko Labs, with sites at three cancer centers in Hawaii, Kentucky, and Massachusetts. No randomization or experimental treatment is involved beyond the use of PointCheck for monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Hawaii Cancer Center
  Honolulu, Hawaii, United States Recruiting
• Norton Healthcare Cancer Center
  Louisville, Kentucky, United States Recruiting
• Massachussetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Hackensack University Medical Center
  Hackensack, New Jersey, United States Recruiting
• Mda
  Houston, Texas, United States Recruiting
• Hospital Universitario 12 de Octubre
  Madrid, Spain Recruiting

Study contacts

• Principal investigator: Carlos Castro Gonzalez, PhD — Leuko Labs
• Study coordinator: Alvaro Sanchez-Ferro, MD, PhD
• Email: alvaro@leuko.io
• Phone: +1 617 419 0974

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.