Spots Global Cancer Trial Database for PC001- A Study to Evaluate the Usability of PointCheck
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Trial Identification
Brief Title: PC001- A Study to Evaluate the Usability of PointCheck
Official Title: PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
Study ID: NCT04448301
Interventions
Study Description
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 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Boston Medical Center, Boston, Massachusetts, United States
Contact Details
Name: Mark Sloan, MD
Affiliation: Boston Medical Center
Role: PRINCIPAL_INVESTIGATOR
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