MedPath

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

Completed
Conditions
Colorectal Cancer
Registration Number
NCT04005742
Lead Sponsor
Newcastle University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
47
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Faecal short-chain fatty acid concentrations12 years (on average)

Concentrations and proportions of short-chain fatty acids e.g. acetate, propionate and butyrate

DNA methylation in rectal mucosal biopsies(% methylation)12 years (on average)

Target gene and global methylation (LINE-1) in rectal mucosal biopsies

Colonic crypt cell dimensions12 years (on average)

Height (length) and width rectal mucosal crypts

Parathyroid hormone in plasma12 years (on average)
Triglycerides in plasma12 years (on average)
Vitamin B12 concentrations in serum12 years (on average)
Folate concentrations in serum12 years (on average)
HDL cholesterol in plasma12 years (on average)
Gut microbiota (analysed in stool samples)12 years (on average)

Abundance and diversity of the gut microbiota assessed in stool samples

Target gene expression in rectal mucosal biopsies12 years (on average)

Expression of genes related to inflammation and the WNT signalling pathway in rectal mucosal biopsies

microRNA expression in rectal mucosal biopsies12 years (on average)

Expression of microRNAs in rectal mucosal biopsies

Colonic crypt cell proliferative state12 years (on average)

Total number and distribution of proliferating cells in rectal mucosal crypts

Markers of mitochondrial function and structure in rectal mucosal biopsies12 years (on average)

Markers of mitochondrial function and structure in rectal mucosal biopsies such as oxidative phosphorylation proteins, namely complex I and IV

25-hydroxy vitamin D concentrations in serum12 years (on average)
LDL cholesterol in plasma12 years (on average)
Glucose in plasma12 years (on average)
HbA1c in whole blood12 years (on average)
Total cholesterol in plasma12 years (on average)

Trial Locations

Locations (1)

North Tyneside General Hospital

🇬🇧

North Shields, Tyne & Wear, United Kingdom

© Copyright 2025. All Rights Reserved by MedPath