Colorectal cancer Cancer
Conditions
Interventions
Single-centre pilot study to assess the ability of a microchip-based system to detect human DNA biomarkers of colorectal cancer in stool and blood samples from colorectal cancer patients.
Patients di
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Participant is willing to comply with all trial procedures 3. Participant is over the age of 18 years 4. Patient diagnosed with colorectal cancer 5. Patient had histology confirming colorectal cancer 6. Patients at any stage of colorectal cancer will be included
Exclusion criteria
Exclusion criteria: 1. Patients aged <18 years old 2. People who are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of colorectal cancer-related human DNA biomarkers in stool and blood samples using the microchip-based system at the time of sample collection from diagnosed patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adaptation of the microchip-based platform to a panel of proposed colorectal cancer genetic markers measured through assay customisation during the development phase. 2. Optimum configuration of the microchip-based platform for detecting predetermined genetic markers assessed through iterative testing during platform setup. 3. Feasibility of amplification and detection of colorectal cancer-specific genetic targets evaluated using synthetic DNA during laboratory testing. 4. Ability of chip-based cartridges to multiplex and synchronously detect multiple DNA reactions assessed during assay development for improved diagnostic accuracy. 5. Simultaneous detection of multiple colorectal cancer-specific genetic markers using extracted human DNA measured during laboratory testing of the microchip-based system. 6. Simultaneous detection of multiple colorectal cancer-specific genetic markers in human blood and stool samples assessed using the microchip-based test during sample analysis. 7. Identification of colorectal cancer-specific genetic targets for inclusion on the microchip determined during assay design and marker selection. 8. Feasibility of the microchip-based test as a lab-free, point-of-care tool assessed through evaluation of usability, speed, and accuracy during prototype testing. 9. Ability of the microchip-based test to identify genetic markers for prognostic and predictive categorisation, which can categorise a patient into a high- or low-risk group, assessed during analysis of patient samples. 10. Ability of the microchip-based test to identify genetic markers predictive of treatment response to specific types of treatment (e.g. chemotherapy agents, radiotherapy) and thus guide personalised cancer treatment evaluated during correlation studies with treatment outcomes. 11. Ability of the microchip-based test to monitor treatment response and post-treatment surveillance assessed through serial sample analysis across different therapy types. Different therapie | — |
Countries
England, United Kingdom
Contacts
Public ContactConstantinos Simillis
Outcome results
None listed