Capillary-Venous Paired Data Collection

NCT05926362 | Suspended

• 1 other identifier: IRAS: 329382
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

Capillary-venous paired data collection.

Conditions

Oncology; Medical Devices; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Coefficient of Variance of the difference between the lab results and the Liberty results

  the coefficient of variance (CV) between the lab results and the liberty results would be compared. a lower CV value signifies a better performance of our device.

  3 years

• Bias (including %bias and absolute bias) between the lab results and the Liberty results

  Bias and absolute difference between the lab results and the liberty results would be compared. a lower bias signifies a better performance of our device.

  3 years

• Regression between the lab results and the Liberty results

  Regression between the lab results and the liberty results would be compared. a value closer to 1.00 signifies a better performance of the Liberty device

  3 years

Secondary Outcomes (2)

• Correlation between the Liberty results of different specimen types (capillary blood vs venous blood)

  3 yaers

• Correlation between the performance of Liberty device between cancer patients and healthy volunteers

  3 years

Study Arms (2)

Cancer Cohort

This cohort are participants who are currently undergoing Systemic Anti-Cancer Treatment

Healthy Cohort

This cohort are participants who do not have any underlying conditions, to be used as a control group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle AND healthy volunteers.

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 venous laboratory blood tests as part of the standard of care
• Able to provide capillary whole blood donation from pricking three different fingers on one hand
• 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 haematological malignancy (including bone and lymph)
• Inadequate use and understanding of the English language, requiring a translator
• HEALTHY COHORT
• Age ≥18 years old at the time of study entry
• Can provide written informed consent
• Have an NHS number (to enable ordering and tracking of laboratory FBC tests)
• Registered with a GP
• In the Investigator's opinion, is able and willing to comply with all study requirements
• Inadequate use and understanding of the English language, requiring a translator
• Been hospitalised within 90 days prior to their study visit
• Donated whole blood or plasma to a blood bank within the 90 days prior to the study visit
• History of vasovagal syncope following blood draw
• History or current diagnosis of the following conditions:
• Cancer
• Cardiovascular disease

Sponsors & Collaborators

• Entia Ltd: lead

Study Sites (2)

Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust

Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom

Location

Wycombe Hospital, Buckinghamshire Healthcare NHS Trust

High Wycombe, Buckinghamshire, HP11 2TT, 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: May 22, 2023
• First Posted: July 3, 2023
• Study Start: February 10, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)