Clinical trial NCT04005742: The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study
Official title: The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colorectal cancer
biomarkers
cancer risk
cancer prevention
ageing
diet
obesity
physical activity
colorectal adenoma
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: Northumbria Healthcare NHS Foundation Trust
First posted: 2019-07-02
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Faecal calprotectin concentrations (marker of local inflammation)
timeFrame: 12 years (on average)
measure: Serum high-sensitivity C-Reactive Protein concentrations (marker of systemic inflammation)
timeFrame: 12 years (on average)
Secondary outcomes:
measure: Gut microbiota (analysed in stool samples)
timeFrame: 12 years (on average)
measure: Faecal short-chain fatty acid concentrations
timeFrame: 12 years (on average)
measure: DNA methylation in rectal mucosal biopsies(% methylation)
timeFrame: 12 years (on average)
measure: Target gene expression in rectal mucosal biopsies
timeFrame: 12 years (on average)
measure: microRNA expression in rectal mucosal biopsies
timeFrame: 12 years (on average)
measure: Colonic crypt cell proliferative state
timeFrame: 12 years (on average)
measure: Colonic crypt cell dimensions
timeFrame: 12 years (on average)
measure: Markers of mitochondrial function and structure in rectal mucosal biopsies
timeFrame: 12 years (on average)
measure: Parathyroid hormone in plasma
timeFrame: 12 years (on average)
measure: 25-hydroxy vitamin D concentrations in serum
timeFrame: 12 years (on average)
measure: Vitamin B12 concentrations in serum
timeFrame: 12 years (on average)
measure: Folate concentrations in serum
timeFrame: 12 years (on average)
measure: Triglycerides in plasma
timeFrame: 12 years (on average)
measure: HDL cholesterol in plasma
timeFrame: 12 years (on average)
measure: LDL cholesterol in plasma
timeFrame: 12 years (on average)
measure: Total cholesterol in plasma
timeFrame: 12 years (on average)
measure: Glucose in plasma
timeFrame: 12 years (on average)
measure: HbA1c in whole blood
timeFrame: 12 years (on average)
Other outcomes:
measure: Timed-up and go test time
timeFrame: 12 years (on average)
measure: Hand grip strength using dynamometer
timeFrame: 12 years (on average)
measure: Heel bone density using Achilles heel ultrasound device
timeFrame: 12 years (on average)
measure: Body weight in kg
timeFrame: 12 years (on average)
measure: BMI in kg/m2 (calculated from height and weight)
timeFrame: 12 years (on average)
measure: Height in cm
timeFrame: 12 years (on average)
measure: Body fat percentage
timeFrame: 12 years (on average)
measure: Habitual dietary intake assessed using Food Frequency Questionnaire
timeFrame: 12 years (on average)
measure: Physical activity levels assessed using Lifestyle Questionnaire
timeFrame: 12 years (on average)
measure: Physical activity levels assessed using accelerometer
timeFrame: 12 years (on average)
measure: Sedentary behaviour assessed using Lifestyle Questionnaire
timeFrame: 12 years (on average)
Locations:
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
state: Tyne & Wear
Study officials:
affiliation: Newcastle University
name: John Mathers
role: PRINCIPAL_INVESTIGATOR
References: