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

Not yet recruiting

• Conditions: Diffuse Large B Cell Lymphoma; Multiple Myeloma

• Registration Number: NCT06323447
• Lead Sponsor: Leuko Labs, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Study Start: 2025-04-01
• Primary Completion: 2026-03-30
• Study Completion: 2026-04-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PointCheck Accuracy	Two weeks	The main primary endpoints for this study will be the sensitivity and specificity of PointCheckTM to detect grade IV neutropenia ac cording to the CTCAE V5 definition of severe neutropenia in a standard blood analysis.

Secondary Outcome Measures

Name	Time	Method
PointCheck Usability	Two-weeks	Mean System Usability Score
PointCheck Precision	Two-weeks	Repeatability and reproducibility will be assessed using the % positive/negative results of the test's classification compared to the gold standard after multiple measurements in different contexts.
PointCheck Safety	Two-weeks	total number (and %) of AEs and SAEs related to the device use.
PointCheck Errors	Two-weeks	Device related errors (number/type)