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NCT04211727 | COMPLETED | Cancer

Affinity: Hospital Trial
Sponsor:

Entia Ltd

Brief Summary:

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)

Condition or disease

Cancer

Intervention/treatment

Capillary finger prick blood sample

Detailed Description:

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 247 participants
Official Title : Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System
Actual Study Start Date : 2020-10-26
Estimated Primary Completion Date : 2022-01-17
Estimated Study Completion Date : 2022-01-17

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Affinity: Hospital Trial

Location Details

NCT04211727

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United Kingdom,

The Christie NHS Foundation Trust

Manchester, United Kingdom,