Clinical trial · Observational
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
NCT06323447CI-TRIAL-00119998PC002active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PointCheck | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- PointCheck Accuracy
- timeFrame
- Two weeks
- description
- 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 (4)
- measure
- PointCheck Precision
- timeFrame
- Two-weeks
- description
- 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.
- measure
- PointCheck Usability
- timeFrame
- Two-weeks
- description
- Mean System Usability Score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.