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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne & Wear
    • North Shields, Tyne & Wear, United Kingdom, NE29 8NH
      • North Tyneside General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants who took part in the BORICC Study at baseline (2005/06) will be invited to participate in the BFU Study. This will include both participants recruited to the BORICC1 arm (healthy participants) and those recruited to the BORICC2 arm, with a prior history of polyps.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy; Participants recruited to the healthy arm of the BORICC Study (BORICC1) at baseline.
Polyp; Participants recruited to the polyp arm of the BORICC Study (BORICC2) at baseline, with a prior history of polyps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed-up and go test time		12 years (on average)
Hand grip strength using dynamometer		12 years (on average)
Heel bone density using Achilles heel ultrasound device		12 years (on average)
Body weight in kg		12 years (on average)
BMI in kg/m2 (calculated from height and weight)		12 years (on average)
Height in cm		12 years (on average)
Body fat percentage	Measured using Tanita Bioimpedance scales	12 years (on average)
Habitual dietary intake assessed using Food Frequency Questionnaire		12 years (on average)
Physical activity levels assessed using Lifestyle Questionnaire		12 years (on average)
Physical activity levels assessed using accelerometer		12 years (on average)
Sedentary behaviour assessed using Lifestyle Questionnaire		12 years (on average)

Collaborators and Investigators

• Sponsor: Newcastle University
• Collaborators: Northumbria Healthcare NHS Foundation Trust
• Investigators: Principal Investigator: John Mathers, Newcastle University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Actual): June 8, 2018
• Study Completion (Actual): June 8, 2018

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: physical activity; colorectal cancer; biomarkers; obesity; diet; ageing; cancer prevention; colorectal adenoma; cancer risk
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 207081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No