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NCT Number: NCT06323447

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PointCheck

Diagnostic Test

Binary classification of severe neutropenia

Primary outcomes

  1. PointCheck Accuracy

    Time frame: 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 outcomes

  1. PointCheck Precision

    Time frame: 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.

  2. PointCheck Usability

    Time frame: Two-weeks

    Mean System Usability Score

  3. PointCheck Errors

    Time frame: Two-weeks

    Device related errors (number/type)

  4. PointCheck Safety

    Time frame: Two-weeks

    total number (and %) of AEs and SAEs related to the device use.

Study contacts

Contact information is provided by the study sponsor or research team.

Alvaro Sanchez-Ferro, MD, PhD

CONTACT

[email protected]

+1 617 419 0974

Sponsors and collaborators

Lead sponsor

Leuko Labs, Inc.

Industry

Registry information

Official study title

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

Acronym: PC002

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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