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NCT06323447Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
210 (estimated)
First submitted
21 Aug 2023
Start date
15 Dec 2025
Primary completion date
30 Jun 2027
Lead sponsor
Leuko Labs, Inc.
NCT number
NCT06323447

What you commit to

  • Study type: Observational
  • Planned participants: 210
  • From 15 Dec 2025 to the primary completion date, 30 Jun 2027
  • 6 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with circulating tumour cells in previous or current lab determinations.

Other illness

  • 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 any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
  • 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

  • Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator.
  • Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
  • Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Who the study is looking for

  • 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.

Age in the registry: 10 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Massachussetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesRecruiting
University of Hawaii Cancer Center
Coordinator of this site? Confirm its status
HonoluluUnited StatesRecruiting
MDA
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Norton Healthcare Cancer Center
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.