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NCT Number: NCT04005742

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

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.

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Key information

Conditions

Colorectal Cancer Behavior Body Weight Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Motor Activity Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

North Tyneside General Hospital

North Shields, Tyne & Wear, NE29 8NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Faecal calprotectin concentrations (marker of local inflammation)

    Time frame: 12 years (on average)

  2. Serum high-sensitivity C-Reactive Protein concentrations (marker of systemic inflammation)

    Time frame: 12 years (on average)

Secondary outcomes

  1. Gut microbiota (analysed in stool samples)

    Time frame: 12 years (on average)

    Abundance and diversity of the gut microbiota assessed in stool samples

  2. Faecal short-chain fatty acid concentrations

    Time frame: 12 years (on average)

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

  3. DNA methylation in rectal mucosal biopsies(% methylation)

    Time frame: 12 years (on average)

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

  4. Target gene expression in rectal mucosal biopsies

    Time frame: 12 years (on average)

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

  5. microRNA expression in rectal mucosal biopsies

    Time frame: 12 years (on average)

    Expression of microRNAs in rectal mucosal biopsies

  6. Colonic crypt cell proliferative state

    Time frame: 12 years (on average)

    Total number and distribution of proliferating cells in rectal mucosal crypts

  7. Colonic crypt cell dimensions

    Time frame: 12 years (on average)

    Height (length) and width rectal mucosal crypts

  8. Markers of mitochondrial function and structure in rectal mucosal biopsies

    Time frame: 12 years (on average)

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

  9. Parathyroid hormone in plasma

    Time frame: 12 years (on average)

  10. 25-hydroxy vitamin D concentrations in serum

    Time frame: 12 years (on average)

  11. Vitamin B12 concentrations in serum

    Time frame: 12 years (on average)

  12. Folate concentrations in serum

    Time frame: 12 years (on average)

  13. Triglycerides in plasma

    Time frame: 12 years (on average)

  14. HDL cholesterol in plasma

    Time frame: 12 years (on average)

  15. LDL cholesterol in plasma

    Time frame: 12 years (on average)

  16. Total cholesterol in plasma

    Time frame: 12 years (on average)

  17. Glucose in plasma

    Time frame: 12 years (on average)

  18. HbA1c in whole blood

    Time frame: 12 years (on average)

Other outcomes

  1. Timed-up and go test time

    Time frame: 12 years (on average)

  2. Hand grip strength using dynamometer

    Time frame: 12 years (on average)

  3. Heel bone density using Achilles heel ultrasound device

    Time frame: 12 years (on average)

  4. Body weight in kg

    Time frame: 12 years (on average)

  5. BMI in kg/m2 (calculated from height and weight)

    Time frame: 12 years (on average)

  6. Height in cm

    Time frame: 12 years (on average)

  7. Body fat percentage

    Time frame: 12 years (on average)

    Measured using Tanita Bioimpedance scales

  8. Habitual dietary intake assessed using Food Frequency Questionnaire

    Time frame: 12 years (on average)

  9. Physical activity levels assessed using Lifestyle Questionnaire

    Time frame: 12 years (on average)

  10. Physical activity levels assessed using accelerometer

    Time frame: 12 years (on average)

  11. Sedentary behaviour assessed using Lifestyle Questionnaire

    Time frame: 12 years (on average)

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Collaborators

  • Northumbria Healthcare NHS Foundation Trust

Registry information

Acronym: BFU

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2019
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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