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
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Massachussetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| University of Hawaii Cancer Center Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| MDA Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Norton Healthcare Cancer Center Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.