Condition or disease |
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Colorectal Cancer |
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 |
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 |
Group/Cohort |
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Healthy
Participants recruited to the healthy arm of the BORICC Study (BORICC1) at baseline.
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Polyp
Participants recruited to the polyp arm of the BORICC Study (BORICC2) at baseline, with a prior history of polyps.
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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 |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
North Tyneside General Hospital | |
North Shields, Tyne & Wear, United Kingdom, NE29 8NH |
Principal Investigator: | John Mathers | Newcastle University |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Other |
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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 |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | Newcastle University | ||||
Study Sponsor | Newcastle University | ||||
Collaborators | Northumbria Healthcare NHS Foundation Trust | ||||
Investigators |
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PRS Account | Newcastle University | ||||
Verification Date | July 2019 |