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出境医 / 临床实验 / The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study (BFU)

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

Study Description
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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study
Actual Study Start Date : March 13, 2017
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2018
Arms 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.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
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
Contacts and Locations

Locations
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United Kingdom
North Tyneside General Hospital
North Shields, Tyne & Wear, United Kingdom, NE29 8NH
Sponsors and Collaborators
Newcastle University
Northumbria Healthcare NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: John Mathers Newcastle University
Tracking Information
First Submitted Date June 25, 2019
First Posted Date July 2, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date March 13, 2017
Actual Primary Completion Date June 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
  • Faecal calprotectin concentrations (marker of local inflammation) [ Time Frame: 12 years (on average) ]
  • Serum high-sensitivity C-Reactive Protein concentrations (marker of systemic inflammation) [ Time Frame: 12 years (on average) ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 1, 2019)
  • Gut microbiota (analysed in stool samples) [ Time Frame: 12 years (on average) ]
    Abundance and diversity of the gut microbiota assessed in stool samples
  • 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
  • DNA methylation in rectal mucosal biopsies(% methylation) [ Time Frame: 12 years (on average) ]
    Target gene and global methylation (LINE-1) in rectal mucosal biopsies
  • 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
  • microRNA expression in rectal mucosal biopsies [ Time Frame: 12 years (on average) ]
    Expression of microRNAs in rectal mucosal biopsies
  • Colonic crypt cell proliferative state [ Time Frame: 12 years (on average) ]
    Total number and distribution of proliferating cells in rectal mucosal crypts
  • Colonic crypt cell dimensions [ Time Frame: 12 years (on average) ]
    Height (length) and width rectal mucosal crypts
  • 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
  • Parathyroid hormone in plasma [ Time Frame: 12 years (on average) ]
  • 25-hydroxy vitamin D concentrations in serum [ Time Frame: 12 years (on average) ]
  • Vitamin B12 concentrations in serum [ Time Frame: 12 years (on average) ]
  • Folate concentrations in serum [ Time Frame: 12 years (on average) ]
  • Triglycerides in plasma [ Time Frame: 12 years (on average) ]
  • HDL cholesterol in plasma [ Time Frame: 12 years (on average) ]
  • LDL cholesterol in plasma [ Time Frame: 12 years (on average) ]
  • Total cholesterol in plasma [ Time Frame: 12 years (on average) ]
  • Glucose in plasma [ Time Frame: 12 years (on average) ]
  • HbA1c in whole blood [ Time Frame: 12 years (on average) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 1, 2019)
  • Timed-up and go test time [ Time Frame: 12 years (on average) ]
  • Hand grip strength using dynamometer [ Time Frame: 12 years (on average) ]
  • Heel bone density using Achilles heel ultrasound device [ Time Frame: 12 years (on average) ]
  • Body weight in kg [ Time Frame: 12 years (on average) ]
  • BMI in kg/m2 (calculated from height and weight) [ Time Frame: 12 years (on average) ]
  • Height in cm [ Time Frame: 12 years (on average) ]
  • Body fat percentage [ Time Frame: 12 years (on average) ]
    Measured using Tanita Bioimpedance scales
  • Habitual dietary intake assessed using Food Frequency Questionnaire [ Time Frame: 12 years (on average) ]
  • Physical activity levels assessed using Lifestyle Questionnaire [ Time Frame: 12 years (on average) ]
  • Physical activity levels assessed using accelerometer [ Time Frame: 12 years (on average) ]
  • Sedentary behaviour assessed using Lifestyle Questionnaire [ Time Frame: 12 years (on average) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Colorectal Cancer
Intervention Not Provided
Study Groups/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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 1, 2019)
47
Original Actual Enrollment Same as current
Actual Study Completion Date June 8, 2018
Actual Primary Completion Date June 8, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04005742
Other Study ID Numbers 207081
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Newcastle University
Study Sponsor Newcastle University
Collaborators Northumbria Healthcare NHS Foundation Trust
Investigators
Principal Investigator: John Mathers Newcastle University
PRS Account Newcastle University
Verification Date July 2019

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