Capillary-Venous Paired Collection (CaVe)

Entia

Status: Not yet enrolling

Conditions: Cancer

Treatments: Device: Entia Liberty System

Study type: Observational

Funder types: Industry

Identifiers

NCT06183151

CAVE-USA

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

150 participants in 1 patient group

Participants

Description:

All participants to undergo the same study method. Where all participants are to donate capillary blood to complete 2 tests on the investigational system and the remnant blood sample from routine CBC testing will also be tested on the investigational system. The routine CBC results will be compared to the results obtained by the investigational system.

Treatment:

Device: Entia Liberty System