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

Colorectal Cancer Clinical Trial

— BFU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005742
• Other study ID #: 207081
• Status: Completed
• Start date: March 13, 2017
• Est. completion date: June 8, 2018

Study information

• Verified date: July 2019
• Source: Newcastle University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 8, 2018
• Est. primary completion date: June 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
United Kingdom	North Tyneside General Hospital	North Shields	Tyne & Wear

Sponsors (2)

Lead Sponsor	Collaborator
Newcastle University	Northumbria Healthcare NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Timed-up and go test time		12 years (on average)
Other	Hand grip strength using dynamometer		12 years (on average)
Other	Heel bone density using Achilles heel ultrasound device		12 years (on average)
Other	Body weight in kg		12 years (on average)
Other	BMI in kg/m2 (calculated from height and weight)		12 years (on average)
Other	Height in cm		12 years (on average)
Other	Body fat percentage	Measured using Tanita Bioimpedance scales	12 years (on average)
Other	Habitual dietary intake assessed using Food Frequency Questionnaire		12 years (on average)
Other	Physical activity levels assessed using Lifestyle Questionnaire		12 years (on average)
Other	Physical activity levels assessed using accelerometer		12 years (on average)
Other	Sedentary behaviour assessed using Lifestyle Questionnaire		12 years (on average)
Primary	Faecal calprotectin concentrations (marker of local inflammation)		12 years (on average)
Primary	Serum high-sensitivity C-Reactive Protein concentrations (marker of systemic inflammation)		12 years (on average)
Secondary	Gut microbiota (analysed in stool samples)	Abundance and diversity of the gut microbiota assessed in stool samples	12 years (on average)
Secondary	Faecal short-chain fatty acid concentrations	Concentrations and proportions of short-chain fatty acids e.g. acetate, propionate and butyrate	12 years (on average)
Secondary	DNA methylation in rectal mucosal biopsies(% methylation)	Target gene and global methylation (LINE-1) in rectal mucosal biopsies	12 years (on average)
Secondary	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)
Secondary	microRNA expression in rectal mucosal biopsies	Expression of microRNAs in rectal mucosal biopsies	12 years (on average)
Secondary	Colonic crypt cell proliferative state	Total number and distribution of proliferating cells in rectal mucosal crypts	12 years (on average)
Secondary	Colonic crypt cell dimensions	Height (length) and width rectal mucosal crypts	12 years (on average)
Secondary	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)
Secondary	Parathyroid hormone in plasma		12 years (on average)
Secondary	25-hydroxy vitamin D concentrations in serum		12 years (on average)
Secondary	Vitamin B12 concentrations in serum		12 years (on average)
Secondary	Folate concentrations in serum		12 years (on average)
Secondary	Triglycerides in plasma		12 years (on average)
Secondary	HDL cholesterol in plasma		12 years (on average)
Secondary	LDL cholesterol in plasma		12 years (on average)
Secondary	Total cholesterol in plasma		12 years (on average)
Secondary	Glucose in plasma		12 years (on average)
Secondary	HbA1c in whole blood		12 years (on average)