NCT06323447 Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
| NCT ID | NCT06323447 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leuko Labs, Inc. |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 210 participants in total. It began in 2025-12-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Carlos Castro Gonzalez, PhD
PRINCIPAL INVESTIGATOR
Leuko Labs
Frequently Asked Questions
Who can join the NCT06323447 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06323447 currently recruiting?
Yes, NCT06323447 is actively recruiting participants. Contact the research team at alvaro@leuko.io for enrollment information.
Where is the NCT06323447 trial being conducted?
This trial is being conducted at Honolulu, United States, Louisville, United States, Boston, United States, Hackensack, United States and 2 additional locations.
Who is sponsoring the NCT06323447 clinical trial?
NCT06323447 is sponsored by Leuko Labs, Inc.. The principal investigator is Carlos Castro Gonzalez, PhD at Leuko Labs. The trial plans to enroll 210 participants.