Capillary-Venous Paired Collection

NCT06183151 | Unknown FDA Device

• 1 other identifier: CAVE-USA
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Participants

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.

Device: Entia Liberty System

Interventions

Entia Liberty System DEVICE

See arm/group description

Participants

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

Cancer patients undergoing treatment and attending clinic for Complete Blood Count (CBC) test

You may qualify if:

• 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

You may not qualify if:

• History or current diagnosis of hematological malignancy (including bone and lymph)

Sponsors & Collaborators

• Entia Ltd: lead

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 27, 2023
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12