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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04005742
Acronym
BFU
Enrollment
47
Registered
2019-07-02
Start date
2017-03-13
Completion date
2018-06-08
Last updated
2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal cancer, biomarkers, cancer risk, cancer prevention, ageing, diet, obesity, physical activity, colorectal adenoma

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.

Interventions

None listed

Sponsors

Northumbria Healthcare NHS Foundation Trust
CollaboratorOTHER
Newcastle University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
microRNA expression in rectal mucosal biopsies12 years (on average)Expression of microRNAs in rectal mucosal biopsies
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
Parathyroid hormone in plasma12 years (on average)
25-hydroxy vitamin D concentrations in serum12 years (on average)
Vitamin B12 concentrations in serum12 years (on average)
Folate concentrations in serum12 years (on average)
Triglycerides in plasma12 years (on average)
HDL cholesterol in plasma12 years (on average)
LDL cholesterol in plasma12 years (on average)
Total cholesterol in plasma12 years (on average)
Glucose in plasma12 years (on average)
HbA1c in whole blood12 years (on average)
Gut microbiota (analysed in stool samples)12 years (on average)Abundance and diversity of the gut microbiota assessed in stool samples
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
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
Colonic crypt cell proliferative state12 years (on average)Total number and distribution of proliferating cells in rectal mucosal crypts
Colonic crypt cell dimensions12 years (on average)Height (length) and width rectal mucosal crypts

Other

MeasureTime frameDescription
Body weight in kg12 years (on average)
BMI in kg/m2 (calculated from height and weight)12 years (on average)
Height in cm12 years (on average)
Body fat percentage12 years (on average)Measured using Tanita Bioimpedance scales
Habitual dietary intake assessed using Food Frequency Questionnaire12 years (on average)
Physical activity levels assessed using Lifestyle Questionnaire12 years (on average)
Physical activity levels assessed using accelerometer12 years (on average)
Sedentary behaviour assessed using Lifestyle Questionnaire12 years (on average)
Heel bone density using Achilles heel ultrasound device12 years (on average)
Timed-up and go test time12 years (on average)
Hand grip strength using dynamometer12 years (on average)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026