Colorectal CancerBFUNCT04005742
The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study
An observational study of Colorectal Cancer, run by Newcastle University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Mar 2017to 8 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Took part in the BORICC Study at baseline (recruited 2005/6)
Who cannot join
- Unable to travel to the hospital to attend study visit
- Unable to provide informed written consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Tyneside General Hospital
North Shields, Tyne & Wear, NE29 8NH
About this 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.
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.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, biomarkers, cancer risk, cancer prevention, ageing, diet, obesity, physical activity, colorectal adenoma
- Medical subject headings
- Colorectal Neoplasms, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal calprotectin concentrations (marker of local inflammation)
Measured: 12 years (on average)
Serum high-sensitivity C-Reactive Protein concentrations (marker of systemic inflammation)
Measured: 12 years (on average)
Secondary outcomes (18)
Gut microbiota (analysed in stool samples)
Abundance and diversity of the gut microbiota assessed in stool samples
Measured: 12 years (on average)
Faecal short-chain fatty acid concentrations
Concentrations and proportions of short-chain fatty acids e.g. acetate, propionate and butyrate
Measured: 12 years (on average)
DNA methylation in rectal mucosal biopsies(% methylation)
Target gene and global methylation (LINE-1) in rectal mucosal biopsies
Measured: 12 years (on average)
Target gene expression in rectal mucosal biopsies
Expression of genes related to inflammation and the WNT signalling pathway in rectal mucosal biopsies
Measured: 12 years (on average)
microRNA expression in rectal mucosal biopsies
Expression of microRNAs in rectal mucosal biopsies
Measured: 12 years (on average)
Colonic crypt cell proliferative state
Total number and distribution of proliferating cells in rectal mucosal crypts
Measured: 12 years (on average)
Colonic crypt cell dimensions
Height (length) and width rectal mucosal crypts
Measured: 12 years (on average)
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
Measured: 12 years (on average)
Parathyroid hormone in plasma
Measured: 12 years (on average)
25-hydroxy vitamin D concentrations in serum
Measured: 12 years (on average)
Vitamin B12 concentrations in serum
Measured: 12 years (on average)
Folate concentrations in serum
Measured: 12 years (on average)
Triglycerides in plasma
Measured: 12 years (on average)
HDL cholesterol in plasma
Measured: 12 years (on average)
LDL cholesterol in plasma
Measured: 12 years (on average)
Total cholesterol in plasma
Measured: 12 years (on average)
Glucose in plasma
Measured: 12 years (on average)
HbA1c in whole blood
Measured: 12 years (on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start13 Mar 2017
- Primary completion8 Jun 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- John Mathers, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005742
- Sponsor's protocol ID
- 207081
- Acronym
- BFU
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biomarkers Of RIsk of Colorectal Cancer (BORICC) Follow-Up (BFU) Study
- ClinicalTrials.gov ID
- NCT04005742
- Acronym / sponsor ID
- BFU / 207081
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, biomarkers, cancer risk, cancer prevention, ageing, diet, obesity, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- Northumbria Healthcare NHS Foundation Trust
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 8 Jun 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Took part in the BORICC Study at baseline (recruited 2005/6)
Key exclusion criteria (2 listed)
- Unable to travel to the hospital to attend study visit
- Unable to provide informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
18 secondary outcomes
Gut microbiota (analysed in stool samples)
Time frame: 12 years (on average)
Faecal short-chain fatty acid concentrations
Time frame: 12 years (on average)
DNA methylation in rectal mucosal biopsies(% methylation)
Time frame: 12 years (on average)
Target gene expression in rectal mucosal biopsies
Time frame: 12 years (on average)
microRNA expression in rectal mucosal biopsies
Time frame: 12 years (on average)
Colonic crypt cell proliferative state
Time frame: 12 years (on average)
Colonic crypt cell dimensions
Time frame: 12 years (on average)
Markers of mitochondrial function and structure in rectal mucosal biopsies
Time frame: 12 years (on average)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Mathers principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Newcastle University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal calprotectin concentrations (marker of local inflammation) (time frame: 12 years (on average)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.