The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study

Study Overview
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Brief Summary
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Worldwide, colorectal cancer is the 3rd most common cancer; risk increases with age and is modified by lifestyle factors notably diet, physical activity and obesity. The BORICC Follow-Up (BFU) Study is a 12+ year follow-up of participants recruited to the Biomarkers of Risk of Colon Cancer (BORICC) Study. This longitudinal study will investigate associations between ageing and lifestyle factors and a panel of molecular biomarkers linked with colorectal cancer risk.

Detailed Description
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The BORICC Follow-Up (BFU) Study builds on the findings from the BORICC Study where the investigators observed associations between age and nutritional factors, including selenium and folate, and biomarkers of colorectal health. The BFU Study will investigate the relationships between ageing (12+ years) and such biomarkers longitudinally. It is anticipated that the project will produce novel data on (i) changes in biomarkers of colorectal cancer risk with age and (ii) the effects of obesity and lifestyle factors on biomarkers of colorectal cancer risk. These biomarkers include differentially expressed proteins, DNA methylation markers and inflammation markers.

Official Title
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The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study

Conditions
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Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Took part in the BORICC Study at baseline (recruited 2005/6) Exclusion Criteria: Unable to travel to the hospital to attend study visit Unable to provide informed written consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>Participants recruited to the healthy arm of the BORICC Study (BORICC1) at baseline. | |
| Polyp<br>Participants recruited to the polyp arm of the BORICC Study (BORICC2) at baseline, with a prior history of polyps. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faecal calprotectin concentrations (marker of local inflammation) |  | 12 years (on average) | 
| Serum high-sensitivity C-Reactive Protein concentrations (marker of systemic inflammation) |  | 12 years (on average) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota (analysed in stool samples) | Abundance and diversity of the gut microbiota assessed in stool samples | 12 years (on average) | 
| Faecal short-chain fatty acid concentrations | Concentrations and proportions of short-chain fatty acids e.g. acetate, propionate and butyrate | 12 years (on average) | 
| DNA methylation in rectal mucosal biopsies(% methylation) | Target gene and global methylation (LINE-1) in rectal mucosal biopsies | 12 years (on average) | 
| Target gene expression in rectal mucosal biopsies | Expression of genes related to inflammation and the WNT signalling pathway in rectal mucosal biopsies | 12 years (on average) | 
| microRNA expression in rectal mucosal biopsies | Expression of microRNAs in rectal mucosal biopsies | 12 years (on average) | 
| Colonic crypt cell proliferative state | Total number and distribution of proliferating cells in rectal mucosal crypts | 12 years (on average) | 
| Colonic crypt cell dimensions | Height (length) and width rectal mucosal crypts | 12 years (on average) | 
| Markers of mitochondrial function and structure in rectal mucosal biopsies | Markers of mitochondrial function and structure in rectal mucosal biopsies such as oxidative phosphorylation proteins, namely complex I and IV | 12 years (on average) | 
| Parathyroid hormone in plasma |  | 12 years (on average) | 
| 25-hydroxy vitamin D concentrations in serum |  | 12 years (on average) | 
| Vitamin B12 concentrations in serum |  | 12 years (on average) | 
| Folate concentrations in serum |  | 12 years (on average) | 
| Triglycerides in plasma |  | 12 years (on average) | 
| HDL cholesterol in plasma |  | 12 years (on average) | 
| LDL cholesterol in plasma |  | 12 years (on average) | 
| Total cholesterol in plasma |  | 12 years (on average) | 
| Glucose in plasma |  | 12 years (on average) | 
| HbA1c in whole blood |  | 12 years (on average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, biomarkers, cancer risk, cancer prevention, ageing, diet, obesity, physical activity, colorectal adenoma