Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Heart and Blood Diseases

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Neutropenia

Lymphoma, B-Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphatic Diseases

Agranulocytosis

Leukopenia

Cytopenia

Leukocyte Disorders

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Granulocytopenia

Binary classification of severe neutropenia

PointCheck

Alvaro Sanchez-Ferro, MD, PhD

Carlos Castro Gonzalez, PhD

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.

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

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.

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.

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

Leuko Labs, Inc.

Hematologic Neoplasms

The study will include a sample of patients with specific cancer types visiting the outpatient hematologic oncology clinic for their standard of care chemotherapy administration. Participants will need to be willing to participate and be able to provide written informed consent

PointCheckTM is intended for use to aid in the assessment of severe neutropenia in the home or clinic setting in subjects receiving myelosuppressive chemotherapy with intermediate to high febrile neutropenia risk. The device non-invasively captures real-time videos of blood flow in the nailfold microcirculation and utilizes visible light, a microscope and a computer vision software to provide a qualitative result. The device is limited to use as a preliminary assessment tool in conjunction with standard of care, including temperature monitoring and clinical assessment. It is not to be used as a stand-alone determinant of severe neutropenia or for any other diagnostic purpose

Alvaro Sánchez-Ferro, MD, PhD

Branko Cuglievan, MD

Single-site non-significant risk, open-label clinical investigation designed to validate the usability, adherence, and preliminary diagnostic performance of a novel technology to detect neutropenia. Study participants will be managed as per the standard of care practice with a baseline and nadir visit including laboratory determinations. Participants will also be evaluated with the device at both time points and with daily measurements during the two-week period in between.

Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population

A Study to Evaluate the Usability, Adherence and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia

IPD will not be shared with other researchers

An exploratory analysis about the number of days before the second lab determination that PointCheckTM detected severe neutropenia will be investigated in those participants with severe neutropenia at the nadir visit. Also, exploratory analysis will be conducted in patients developing febrile neutropenia (axillary temperature ≥100.4°F and grade III/IV neutropenia documented in the lab report) during the study to evaluate how many days before the appearance of fever the device detected severe neutropenia during the at home phase of the study.

The preliminary diagnostic accuracy to detect grade III neutropenia according to CTCAE V5 (\<1000 ANC/mm3) 13 measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired at the nadir (follow up) visit.

Survey completed by the clinical team at the baseline visit assessing the clinical utility of PointCheckTM

The study will confirm if participants can acquire good quality videos in a home like setting.

The System Usability Scale (0-100 higher scored indicate a better usability) will be completed by the participants after completing the follow up visit.

The preliminary diagnostic accuracy to detect grade IV neutropenia according to CTCAE V5 (\<500 ANC/mm3) measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired at the nadir (follow up) visit.

The % agreement of the device to classify neutropenia compared to the laboratory reference will be established

The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint

The number of days that the participant used the device will be used to evaluate adherence.

M.D. Anderson Cancer Center

Center for Advancing Point of Care Technologies in Heart, Lung, Blood and Sleep Disorders

This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia

Mark Sloan, MD

This a study about the usability of PointCheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia.

The study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. A final sample size of 90 oncologic outpatients will be enrolled and studied with the technology.

The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a preliminary assessment of PointCheck diagnostic accuracy and precision.

For this, study subjects will be tested twice with PointCheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated

PC001- A Study to Evaluate the Usability of PointCheck

PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia

The preliminary diagnostic accuracy to detect grade III neutropenia according to CTCAE V5 (\<1000 ANC/mm3) measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired.

To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the number of errors of correct videos acquired for analyses.

To confirm the usability of the system using the System Usability Scale

To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status from two independent one-minute videos.

To perform a exploratory analysis of PointCheck's accuracy (e.g., sensitivity, specificity, predictive values) to detect severe neutropenia compared with the gold standard blood analysis method employed by Boston Medical Center core laboratory in the range between ≤500 and \>500 absolute neutrophil count/µL.

To evaluate the number of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.

To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia	NCT06323447	Diffuse Large B... Multiple Myelom...	PointCheck	10 Years -	Leuko Labs, Inc.
Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population	NCT04889937	Hematologic Mal...	PointCheck	7 Years - 39 Years	Leuko Labs, Inc.
PC001- A Study to Evaluate the Usability of PointCheck	NCT04448301	Neoplasms Neutropenia	PointCheck	18 Years -	Leuko Labs, Inc.

Spots Global Cancer Trial Database for pointcheck

Every month we try and update this database with for pointcheck cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pointcheck

Every month we try and update this database with for pointcheck cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pointcheck cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.