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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 10 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Leuko Labs, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Carlos Castro Gonzalez, PhD
Principal Investigator Affiliation Leuko Labs
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Not yet recruiting

The disease, disorder, syndrome, illness, or injury that is being studied.

Diffuse Large B Cell Lymphoma, Multiple Myeloma

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Alvaro Sanchez-Ferro, MD, PhD


+1 617 419 0974

For additional contact information, you can also visit the trial on clinicaltrials.gov.