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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06323447
Other study ID # PC002
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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, ParkinsonĀ“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


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
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