Study to Evaluate the Usability of PointCheck

NCT04448314 | Completed

• 1 other identifier: PC001-EU
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 3

Brief Summary

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 60 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.

Conditions

Neoplasms; Chemotherapy-induced Neutropenia

Keywords

Medical Device; Technology

Outcome Measures

Primary Outcomes (2)

• PointCheck's Usability

  To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the the number and % of user errors (globally and per error type) observed in the clinic visits. In addition, the number and % of users successfully completing the test without errors will be measured.

  Up to three-weeks

• System Usability Scale (0-100 higher scores indicate better usability)

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

  Up to three-weeks

Secondary Outcomes (4)

• PointCheck's Precision

  Up to three-weeks

• PointCheck's Accuracy

  Up to three-weeks

• PointCheck's Utility

  Up to three-weeks

• PointCheck's Safety: total number (%) of AEs and SAEs

  Up to three-weeks

Other Outcomes (1)

• Exploratory diagnostic performance for a second cutoff

  Up to three-weeks

Interventions

PointCheck DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in participants with malignancies who are scheduled to receive cytotoxic chemotherapy agents with any risk of neutropenia (e.g. antimetabolites, platins, taxanes, topoisomerase inhibitors, Vinca alkaloids, anthracyclines, among others). Participants will be in an ambulatory stable condition as described in the criteria below and according to the investigator's assessment.

You may qualify if:

• Study subjects must be 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 18 years or above
• Diagnosed with hematological malignancy (e.g., lymphoma, myeloma) or breast cancer.
• Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.
• Able (in the Investigators 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 tumor cells in previous or current lab determinations.
• 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

Study Sites (3)

Hospital Universitari Dexeus. Grupo Quirónsalud

Barcelona, 08028, Spain

Location

Breast Unit. Oncology Department. 12 Octubre Hospital

Madrid, 28041, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28049, Spain

Location

Related Publications (1)

• Lamaj G, Pablo-Trinidad A, Butterworth I, Bell N, Benasutti R, Bourquard A, Sanchez-Ferro A, Castro-Gonzalez C, Jimenez-Ubieto A, Baumann T, Rodriguez-Izquierdo A, Pottier E, Shelton A, Martinez-Lopez J, Sloan JM. Usability Evaluation of a Noninvasive Neutropenia Screening Device (PointCheck) for Patients Undergoing Cancer Chemotherapy: Mixed Methods Observational Study. J Med Internet Res. 2022 Aug 9;24(8):e37368. doi: 10.2196/37368.

  PMID: 35943786 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Joaquin Martinez López, MD

  Fundación de Investigación del Hospital 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 25, 2020
• Study Start: February 11, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-03

Locations

ES (3)