TAPSPECT
Research type
Research Study
Full title
Phase two prospective observational performance evaluation trial of venepuncture versus TAP II blood sampling using serum Raman spectroscopy in a colorectal cancer population.
IRAS ID
324836
Contact name
Dean Harris
Contact email
Sponsor organisation
Swansea Bay University Health Board
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Background
There is growing interest in the use of blood testing (‘liquid biopsy’) to detect cancers in a non-invasive manner. The ability to perform blood sampling at home without the need for a blood sampling appointment would be of value for certain patient groups yet poses the challenge of producing a smaller blood volume.
Raman spectroscopy analysis of blood serum has shown good levels of accuracy for detecting colorectal cancer and adenomas. The aim of this proof of concept study is to assess the test performance of Raman spectroscopy analysis of blood in the detection of colorectal cancer using a commercial blood sampling device (TAP II).
Method
This study will recruit patients with confirmed colorectal cancer and control patients from a single centre. Up to 40 participants will be invited to attend a research clinic to have a conventional serum blood sample and a paired serum sample obtained under supervision using the TAP II device, or two serum samples at the same time using two TAP-II devices so that stability of the samples can be measured. Both samples will be analysed on the Raman spectroscopy instrument. Maximal serum volume will be recorded. Comparability of the spectral output between the two methods will be measured.
Impact
The availability of an at-home colorectal cancer detection test would have a large impact on compliance with bowel cancer screening and could be deployed as a primary care test for triage of bowel symptoms.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0042
Date of REC Opinion
17 Apr 2023
REC opinion
Further Information Favourable Opinion