COMPLETED

PC001- A Study to Evaluate the Usability of PointCheck

Conditions

Neoplasms Neutropenia Medical Device Technology Non-invasive

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-02-09

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04448301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Male or Female aged 18 years or above. 3. Diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer. 4. Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia. 5. Able (in the Investigators opinion) and willing to comply with all study requirements 1. Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator. 2. 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. 3. Participants with circulating tumour cells in previous or current lab determinations. 4. Participants with leukemia. 5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor). 6. Inadequately medically controlled hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg). 7. Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device. 8. 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. 9. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Male or Female aged 18 years or above.
3. Diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer.
4. Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.
5. Able (in the Investigators opinion) and willing to comply with all study requirements
1. Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.
2. 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.
3. Participants with circulating tumour cells in previous or current lab determinations.
4. Participants with leukemia.
5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
6. Inadequately medically controlled hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
7. Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.
8. 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.
9. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Mark Sloan, MD

PRINCIPAL_INVESTIGATOR

Boston Medical Center

Study Locations (Sites)

Boston Medical Center

Boston, Massachusetts, 02118

United States

Collaborators and Investigators

Sponsor: Leuko Labs, Inc.

Mark Sloan, MD, PRINCIPAL_INVESTIGATOR, Boston Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-09

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2021-02-09

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

Medical Device
Technology
Non-invasive

Additional Relevant MeSH Terms

Neoplasms
Neutropenia