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OpenTrials
Completed

NCT Number: NCT04211727

Affinity: Hospital Trial

Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2)

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust

Manchester, United Kingdom

About this study

In this study the Investigators wish to compare 200 finger prick sample (capillary) blood results taken and analysed using the Affinity prototype device to standard of care venous blood samples, taken from the participant on the same day. The blood tests will analyse Full Blood Count (FBC)

200 patients will be recruited in total. 100 will take part in Cohort 1, where a member of the clinical research team will take their blood sample using the Affinity prototype device. The other 100 will take part in Cohort 2, where the participant will self test and take the blood sample themselves. Participants will be asked to complete a short questionnaire after using the device to provide any feedback on its design and use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle
  • Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
  • Can provide written informed consent
  • Cohort 2 only- Able to independently complete participant questionnaires

Exclusion criteria

  • Receiving systemic anti-cancer therapy for a haematological malignancy
  • Known parasitic infection
  • Known inherited or acquired bleeding disorder
  • History of haematological malignancy
  • Known poorly controlled anti-coagulation
  • Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result

Treatment and study plan

Capillary finger prick blood sample

Diagnostic Test

Patients will have a blood finger prick sample

Primary outcomes

  1. To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample)

    Time frame: 1 year

    Measuring Full Blood Count (FBC)

Secondary outcomes

  1. Assessment and feedback

    Time frame: 1 year

    To measure the number of issues when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2).

  2. Assessment and feedback

    Time frame: 1 year

    To measure the severity of each issue when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2).

Sponsors and collaborators

Lead sponsor

Entia Ltd

Industry

Collaborators

  • The Christie NHS Foundation Trust

Registry information

Official study title

Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 26, 2019
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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