MATCH-1

• Research type

  Research Study

• Full title

  Minimally- invAsive blood Testing for Cancer patients at Home-1

• IRAS ID

  265379

• Contact name

  Susana Banerjee

• Contact email

  susana.banerjee@rmh.nhs.uk

• Sponsor organisation

  The Royal Marsden NHS Foundation Trust

• Duration of Study in the UK

  1 years, 10 months, 18 days

• Research summary

  This is a single-arm, single centre, method-comparison prospective study. This study will recruit up to 200 patients who attend to routine oncology outpatient clinics at the Royal Marsden Hospital.

  The study will be conducted in two parts:
  a) Cohort 1: 100 patients receiving standard of care systemic anti-cancer therapy. These patients will have two capillary blood samples tested by healthcare professionals using the Affinity device. One of the 2 capillary samples will be chosen randomly by the Statistician to be compared to a routinely obtained venous laboratory sample.
  b) Cohort 2: 100 patients receiving standard of care systemic anti-cancer therapy. These patients will self-test a capillary blood sample using the Affinity device in the outpatient clinic and the results compared to a routinely obtained venous laboratory sample. Recruitment is not anticipated to be difficult but cohort 1 participants may be enrolled in cohort 2 as well. This will be collected on their Case Report Forms. Cohort 2 recruitment will commence after the analysis and presentation of the Cohort 1 data to the Trial Management Group.

  The data obtained from Cohort 1 will help to develop the prototype;, a refined version of the prototype may be used in Cohort 2. Whereas the fundamental measuring principle and operation of the prototype will not change between versions, the underlying components and the way a user interacts with the prototype may change. The laboratory results from cohort 1 and 2 will be comparable and show the progression of the prototypes. However, the refined version of the prototype may look different, having a more ergonomic shape, the disposal elements may also be more organic and ergonomic. The user interface may also be geared to allow a lay user to operate the device.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  19/LO/1625

• Date of REC Opinion

  25 Oct 2019

• REC opinion

  Favourable Opinion