Capillary-Venous Paired Collection

NCT06183151 | Suspended

• 1 other identifier: CAVE
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 3

Brief Summary

This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system and venous blood to be tested on a comparator system. At the some sites, additional venous blood samples from the same participants will be tested on the investigation system. The participants' 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 venous blood samples on the investigational system. At certain sites, the usability of the investigational system is observed to evaluate the usability of the 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; Medical Device Performance

Outcome Measures

Primary Outcomes (5)

• To validate the measurement performance of the investigational system

  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

• To validate the usability of the Liberty Analyzer System in a simulated home environment

  Participant to complete a usability questionnaire following use of Liberty. Observer to complete usability checklist during participants' use of Liberty

  Through study completion. Estimated 6 months

• To prove equivalence in the measurement performance between the sampling matrices

  Performance comparison (bias, %bias, regression, CV) between the testing matrices (capillary whole blood and venous whole blood) on Liberty.

  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 3 tests on the investigational system and a comparator venous sample for testing on a comparator system. For certain sites, an additional venous sample will also be tested on the investigational system. The venous CBC results from the comparator system will be compared to the results of both capillary and venous specimens obtained by the investigational system.

Device: Entia Liberty System

Interventions

Entia Liberty System DEVICE

See arm/group description

Participants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients undergoing SACT treatment

You may qualify if:

• Informed Consent signed by the subject
• Age ≥21 years old at the time of study entry
• Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and/or targeted therapy) for solid organ malignancy
• Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care OR willing to undergo a research-specific venous draw to obtain a complete/full blood count (CBC/FBC)

You may not qualify if:

• History or current diagnosis of hematological malignancy (including bone and lymph)
• Patients who self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty, and who do not have a carer who can assist them.
• Patients who have had prior experience using Liberty
• Inadequate use and understanding of the English language, requiring a translator
• Carer eligibility:
• Age ≥ 21 years old at the time of study entry
• Can provide written informed consent
• Do NOT self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty
• Have NOT had prior experience using Liberty
• Adequate use and understanding of the English language; NOT requiring a translator

Sponsors & Collaborators

• Entia Ltd: lead

Study Sites (3)

Baylor Scott & White - Temple

Temple, Texas, 76508, United States

Location

Queen Margaret Hospital

Dunfermline, Fife, KY12 0SU, United Kingdom

Location

North Wales Clinical Research Facility

Wrexham, Wrexham County Borough, LL13 7YP, United Kingdom

Location

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: August 13, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

GB (2); US (1)