Clinical trial NCT06323447: Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Official title: Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diffuse Large B Cell Lymphoma
Multiple Myeloma
Lead sponsor: Leuko Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 210
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a multi-site (4 US sites) observational open-label diagnostic study of a non-significant risk medical device, PointCheckTM. Participants (N=210) with specific malignancies who are scheduled to receive antineoplastic therapy will be evaluated during their routine management before the planned cytotoxic drug administration at two-time points (baseline and nadir evaluation). This will be an event-driven study with a total number of 70 positive cases (ANC \< 500 cells/mm3) and 140 negative cases (ANC \>= 500 cells/mm3) has been considered sufficient to provide accurate estimates of Sensitivity and Specificity. They will have concurrent evaluations with PointCheckTM and a blood differential cell count in addition to the standard clinical visits. A subset (N=45) of patients will be evaluated for between-instrument reproducibility. Finally, a sub-study (N=30) will confirm the usability of PointCheckTM in the home setting.

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.

Primary outcomes:
measure: PointCheck Accuracy
timeFrame: Two weeks
Secondary outcomes:
measure: PointCheck Precision
timeFrame: Two-weeks
measure: PointCheck Usability
timeFrame: Two-weeks
measure: PointCheck Errors
timeFrame: Two-weeks
measure: PointCheck Safety
timeFrame: Two-weeks
Other outcomes:
Locations:
Study officials:
affiliation: Leuko Labs
name: Carlos Castro Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References: