Pilot study to assess the diagnostic accuracy of a microchip-based Lab-on-Chip system for the detection of genetic biomarkers of colorectal cancer at the point-of-care
Colorectal cancer
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 diagnosed with colorectal cancer will be contacted to enquire if they would like to participate in this trial. Only members of the patient's existing clinical care team will have access to patient records without explicit consent in order to identify potential participants, check whether they meet the inclusion criteria or make the initial approach to patients to enquire if they are interested to learn more information about the study. If potential participants express interest to learn more about the study, they will be contacted by the research team. Potential participants will be provided with the participant information sheet, study team contact details, eligibility form, consent form and baseline questionnaire. The research team will try to make arrangements for the patients to participate in the study when they attend the hospital for any reason, e.g. when they attend for an outpatient clinic appointment, or for further diagnostic tests, or for treatment, or as inpatients. Participants to the trial will be asked if they can provide a sample of their blood and stool. This microchip-based test is designed as a point-of-care to test tumour genetic specific to colorectal cancer in blood and stools. The participants will be able to collect a stool sample themselves in their own privacy at home, if possible. Faecal collection kits will be provided to each participant by post or provided when they attend hospital for any reason. A single faecal sample will be collected at home or at the hospital by participants according to instructions within each test kit and guidance will be provided. If participants collect the stool sample at home, they can bring the faecal sample with them when they attend the hospital for any reason, or the sample can be posted. When the participan
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
1. Patients aged <18 years old 2. People who are unable to give informed consent