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

NCT ID: NCT06323447

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-04-28

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

PointCheck

Binary classification of severe neutropenia

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leuko Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Castro Gonzalez, PhD

Role: PRINCIPAL_INVESTIGATOR

Leuko Labs

Central Contacts

Alvaro Sanchez-Ferro, MD, PhD

Role: CONTACT

alvaro@leuko.io

+1 617 419 0974

Other Identifiers

PC002

Identifier Type: -

Identifier Source: org_study_id