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

Multiple Myeloma Clinical Trial

— PC002  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323447
• Other study ID #: PC002
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: May 28, 2025

Study information

• Verified date: March 2024
• Source: Leuko Labs, Inc.
• Contact: Alvaro Sanchez-Ferro, MD, PhD
• Phone: +1 617 419 0974
• Email: alvaro[@]leuko.io
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: May 28, 2025
• Est. primary completion date: April 30, 2025
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Multiple Myeloma
• Neutropenia

Intervention

Diagnostic Test:
• PointCheck
Binary classification of severe neutropenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leuko Labs, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PointCheck Accuracy	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.	Two weeks
Secondary	PointCheck Precision	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.	Two-weeks
Secondary	PointCheck Usability	Mean System Usability Score	Two-weeks
Secondary	PointCheck Errors	Device related errors (number/type)	Two-weeks
Secondary	PointCheck Safety	total number (and %) of AEs and SAEs related to the device use.	Two-weeks