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NCT06183151 Clinical Trial

Capillary-Venous Paired Collection

Cancer Clinical Trial

— CaVe  

Official title:
CApillary-VEnous Paired Collection (CAVE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06183151
Other study ID # CAVE-USA
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2024
Est. completion date May 2024

Study information
Verified date December 2023
Source Entia Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is recruiting participants to donate 2 capillary blood samples to be tested on the investigational system. At the same time, remnant routine blood samples used for Complete Blood Count (CBC) testing from the same participants will be tested on the investigation system. The participants' routine CBC results analyzed on the gold standard laboratory analyzer (comparator) will be collected and compared against the results obtained from the testing of capillary blood samples and remnant blood samples on the investigational system. The participants' involvement in the study is only for the duration of collecting the blood samples. No follow-up is anticipated. The results from the investigational system is for research use only and will not inform or change the participants' treatment or care.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years old at the time of study entry - Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy - Scheduled to be undergoing routine CBC blood tests as part of standard of care - Can provide written informed consent - In the Investigator's opinion, is able and willing to comply with all study requirements Exclusion Criteria: - History or current diagnosis of hematological malignancy (including bone and lymph)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Entia Liberty System
See arm/group description

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Entia Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary To validate the measurement performance of the investigational system (bias and %bias) The difference between the measured parameters of the comparator and investigational system will provide the bias (and therefore also the % bias) of the investigational system, which will be checked against pre-determined acceptance criteria. through study completion, estimated 6 months
Primary To validate the measurement performance of the investigational system (regression) The plotted difference between the measured parameters of the comparator and investigational system will provide the regression, which will be checked against pre-determined acceptance criteria. through study completion, estimated 6 months
Primary To validate the measurement performance of the investigational system (CV and SD) The difference between the measured parameters of the comparator and investigational system will inform the Coefficient of Variation and Standard Deviation of the dataset, which will be checked against pre-determined acceptance criteria. through study completion, estimated 6 months
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