Early detection of colorectal cancer Cancer
Conditions
Interventions
There are five sub-studies in this project to investigate the different explanations for differences in the Raman signal seen in the blood of people with/without polyps/colorectal cancer.
Sub-study
Sponsors
Swansea Bay University Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old and over 2. For sub-study A (Metabolomics), informed consent has been obtained for RAMAN-CRC (Groups 1-4) and provided blood serum for Raman spectroscopy and has a corresponding tissue biopsy or resection collected as the standard of care in archives 3. For sub-study B (Gut microbiome): 3.1. Has a confirmed diagnosis of colorectal cancer, benign/inflammatory conditions requiring surgery/biopsies at colonoscopy OR normal colonoscopy/previous history of complete surgical removal of colon and rectum for the control group 3.2. Informed consent obtained for the RAMAN-MOSS study 3.3. Able and willing to provide blood serum and faecal samples 3.4. Corresponding tissue biopsy/resection collected as the standard of care (for CRC and benign/inflammatory bowel disease groups only) 4. For sub-study C (Fasting state study): 4.1. Has a confirmed diagnosis of CRC (for CRC group) 4.2. Has normal colonoscopy (for the control group) 4.3. Informed consent obtained for the RAMAN-MOSS study 4.4. Able and willing to undergo oral glucose tolerance test 4.5. Able and willing to provide blood serum samples for Raman spectroscopy 5. For sub-study D (Lipid study): 5.1. Known diagnosis of hyperlipidaemia and referred to hyperlipidaemia clinic 5.2. Informed consent obtained for the RAMAN-MOSS study 5.3. Able and willing to provide blood serum sample for Raman spectroscopy 6. For sub-study E (Bowel preparation and Antibiotics study): 6.1. Referred for colonoscopy for investigation of bowel symptoms OR under colonoscopy surveillance programme OR undergoing surgical resection 6.2. Fit for bowel preparation 6.3. Informed consent obtained for the RAMAN-MOSS study 6.4. Able and willing to provide blood serum and faecal samples
Exclusion criteria
Exclusion criteria: 1. Aged 17 years old and under 2. Unwilling/unable to consent to trial participation 3. Patients from vulnerable groups (defined as lacking the capacity to freely give informed consent) 4. Unwilling/unable to provide blood/faecal/tissue samples required for the study 5. Additional for sub-study C (Fasting state): 5.1. Glucose tolerance test (OGTT) contraindicated 5.2. Diagnosis of diabetes 6. Additional for sub-study E (bowel preparation and antibiotics): 6.1. Unfit for bowel preparation or colonoscopy 6.2. Allergy to bowel preparation and/or antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spectral signatures defining CRC and polyp/adenoma detection measured using Raman spectroscopy of study samples in the laboratory at one timepoint (unless otherwise specified in specific sub-study) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be assessed in the laboratory at one timepoint: 1. Sub-study A (Metabolomics and Genomics) - Metabolites that correspond to peaks seen in the Raman spectra in serum samples and tissue samples from patients measured using mass spectrometry and RNA extracted from tissue samples for analysis 2. Sub-study B (Gut microbiome) - Metabolites related to pathobionts in the samples from participants with colorectal cancer, polyps/adenoma. Variables measured using Raman spectroscopy on blood, faecal, tissue and cell media, mass spectrometry on blood, faecal samples and cell media, 16s rRNA sequencing on faecal samples and an inflammatory panel and genomic tests on cells. Organoids derived from patient tissue will also be used to study the effects of gut bacteria using co-culture techniques. Samples were collected at two timepoints - at enrolment or prior to surgery and at their first follow-up appointment 6-8 weeks after surgery. 3. Sub-study C (Fasting state) - Ideal fasting time for the oral glucose tolerance test measured using the Raman test at baseline, and 30, 60, 90 mins, and 4 hours 4. Sub-study D (Lipids) - Level of lipaemia in serum measured using Raman spectra 5. Sub-study E (Bowel preparation) - Colorectal cancer/polyp/adenoma signal in the serum of patients measures using Raman spectroscopy | — |
Countries
United Kingdom, Wales
Contacts
Public ContactAlethea Tang
Outcome results
None listed