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

NCT06323447 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PC002
• Study Type: observational
• Target: 210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diffuse Large B Cell Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• PointCheck Precision

  Two-weeks

• PointCheck Usability

  Two-weeks

• PointCheck Errors

  Two-weeks

• PointCheck Safety

  Two-weeks

Interventions

PointCheck DIAGNOSTIC_TEST

Binary classification of severe neutropenia

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leuko Labs, Inc.: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Multiple Myeloma

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Carlos Castro Gonzalez, PhD

  Leuko Labs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alvaro Sanchez-Ferro, MD, PhD

CONTACT

+1 617 419 0974; alvaro@leuko.io

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: March 21, 2024
• Study Start: April 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 28, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10