Affinity: Hospital Trial V1.0

• Research type

  Research Study

• Full title

  Affinity: Hospital Trial. Early prototype testing for a home oncology monitoring system.

• IRAS ID

  275879

• Contact name

  Jennifer Stuart

• Contact email

  jennifer@entia.co

• Sponsor organisation

  Entia Ltd

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  In this method comparison study we wish to compare 200 finger prick samples (capillary) blood results taken from a participant and analysed using the Affinity prototype device to the participants standard of care venous blood samples taken on the same day. Participants will be patients undergoing systemic anti-cancer therapy (SACT).

  The blood tests will analyse the below parameters:

  or the following haematological parameters:
  a) Haemoglobin (Hb)
  b) Total white cell count (WBC)
  c) Platelet count (PLT)
  d) Neutrophil count (ANC)

  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 after training from the research nurse.

  Participants in Cohort 2 will be asked to complete a short questionnaire after using the device to provide any feedback on its design and use. Participants will only be involved for one visit. To take part they should fit the below criteria:

  Inclusion
  -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

  Exclusion
  -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 - Additional Criteria
  Inclusion
  Able to independently complete participant questionnaires

  Exclusion
  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

  The study is sponsored by Entia and funded by Innovate UK. The research trial will be carried out at The Christie NHS Foundation Trust.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  20/LO/0076

• Date of REC Opinion

  31 Jan 2020

• REC opinion

  Unfavourable Opinion