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CompletedNCT04005742BFUUpdated Jul 2, 2019

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

An observational study in Colorectal Cancer, sponsored by Newcastle University. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2019-07-02.

Sponsored by Newcastle University · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
47
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • colorectal cancer
  • biomarkers
  • cancer risk
  • cancer prevention
  • ageing
  • diet
  • obesity
  • physical activity
  • colorectal adenoma
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 47 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Newcastle University is the lead sponsor of 59 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • Took part in the BORICC Study at baseline (recruited 2005/6)

Exclusion criteria

Exclusion Criteria:

  • Unable to travel to the hospital to attend study visit
  • Unable to provide informed written consent
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
47 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

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)

    Abundance and diversity of the gut microbiota assessed in stool samples

    Time frame: 12 years (on average)

  2. Faecal short-chain fatty acid concentrations

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

    Time frame: 12 years (on average)

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

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

    Time frame: 12 years (on average)

  4. Target gene expression in rectal mucosal biopsies

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

    Time frame: 12 years (on average)

  5. microRNA expression in rectal mucosal biopsies

    Expression of microRNAs in rectal mucosal biopsies

    Time frame: 12 years (on average)

  6. Colonic crypt cell proliferative state

    Total number and distribution of proliferating cells in rectal mucosal crypts

    Time frame: 12 years (on average)

  7. Colonic crypt cell dimensions

    Height (length) and width rectal mucosal crypts

    Time frame: 12 years (on average)

  8. 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

    Time frame: 12 years (on average)

  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

    Measured using Tanita Bioimpedance scales

    Time frame: 12 years (on average)

  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)

07

Study locations

1 site
  • North Tyneside General Hospital
    North Shields, Tyne & Wear NE29 8NH, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04005742
Lead sponsor
Newcastle University
Collaborators
Northumbria Healthcare NHS Foundation Trust
Responsible party
Sponsor
First posted
Jul 2, 2019
Start date
Mar 13, 2017
Primary completion
Jun 8, 2018
Completion
Jun 8, 2018
Last update
Jul 2, 2019

Study contacts

John Mathers
principal investigator · Newcastle University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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