Colorectal CancerNCT04185779
COLO-COHORT (Colorectal Cancer Cohort) Study
An observational study of Colorectal Cancer and Colorectal Adenoma, run by South Tyneside and Sunderland NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
This is a cross-sectional study aimed at identifying factors which best predicts patients at high risk of colorectal cancer or colorectal adenomas and to develop a risk prediction model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma, Colorectal Neoplasm
- What is being tested?
- Colonoscopy
- How many people
- 15,000 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 13 Dec 2019to 15 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have been referred for a colonoscopy (minimum age limits as above in inclusion criteria) either through the bowel cancer screening programme, as part of a surveillance programme or due to symptoms
Who may be able to join
- Group A
- Aged ≥30 years* and able to give informed consent
- Patients attending colonoscopy
- Through Bowel Cancer Screening Programme (FIT positive, Bowelscope conversion, surveillance)
- Through standard NHS care (most commonly due to iron deficiency anaemia, altered bowel habit, weight loss, rectal bleeding, planned polypectomy**, those referred on basis of family history, abnormal cross-sectional imaging, polyp surveillance or post CRC surveillance)
- The age of 30 was chosen to ensure that this is a population likely to be enriched for colorectal neoplasia with neoplasia below this age uncommon **In those attending for planned polypectomy, the results from the initial colonoscopy and the endoscopy where the polypectomy is undertaken will be summated for purposes of calculating the neoplasia profile
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- (COLO-SPEED) Group B
- Any patient attending for colonoscopy and able to give informed consent
- ≥ 18 years old
- Patient from the North of England
Who cannot join
- Group A
- Unable to give informed consent
- Known polyposis syndrome
- Previous total colectomy
- Known colonic stricture which would limit complete colonoscopy
- Attending for planned therapeutic procedure other than polypectomy, such as insertion of colonic stent
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- Attending for assessment of known inflammatory bowel disease (IBD) activity or for IBD surveillance
- Patients currently recruited into an interventional CTIMP for CRC prevention*
- COLO-SPEED (Group B)
- Unable to give informed consent
- Not in a centre supported by COLO-SPEED infrastructure (North of England)
Trial locations and contacts
3 sites in 1 country.
Amy Burns contact
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Kettering General Hospitals NHS Foundation Trust
Kettering, NN16 8UZ
Ajay Verma, ajay.verma@nhs.net
- Recruiting
South Tyneside and Sunderland NHS Foundation Trust
South Shields, Tyne and Wear, NE34 0PL
Colin Rees, colin.rees@stft.nhs.uk
- Recruiting
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, TS19 8PE
Roisin Bevan, Roisin.Bevan@nth.nhs.uk
About this study
This is a cross-sectional study aimed at identifying factors which best predicts patients at high risk of colorectal cancer or colorectal adenomas and to develop a risk prediction model.
Read the detailed description
Bowel cancer is the second commonest cause of cancer death in the UK with 16000 people dying per year. Although the NHS Bowel Cancer Screening Programme (BCSP) detects cancers at an earlier stage only 10% of all cancers are detected through screening.
Currently, the only criteria for screening is age and no account is taken of other known risk factors such as smoking, alcohol, family history or obesity. Stool FIT (a new stool test which detects blood that can't be seen with the naked eye) will be introduced into the English BCSP, but there is poor evidence for its use in patients presenting with symptoms. There is also emerging data that there may be differences in the gut bacteria of people with and without cancer or pre cancerous bowel polyps (adenomas).
This will be a national multi-centre study over 5-years. 10000 Patients undergoing colonoscopy as part of BCSP or due to symptoms will be recruited. Patients will be asked to fill in a health questionnaire, have their height, weight, waist circumference measured. Patients will also receive blood tests, stool tests or saliva tests depending on the indication for their colonoscopy. The results of the colonoscopy and any samples taken will be collated. Patients will receive a patient experience questionnaire or food frequency questionnaire. A further 10,000 patients from the North of England will be consented to be contacted for future studies with some of the information above collected.
The aim of this study is to develop a risk prediction model to help determine which patients are at highest risk of having adenomas or bowel cancer. The investigators will also explore the significance of the gut bacteria composition in patients with adenomas or cancer to help inform this risk model. Additionally the investigators will develop a large platform of patients who consent to be contacted for future research.
- Conditions
- Colorectal Cancer, Colorectal Adenoma, Colorectal Neoplasm, Predictive Cancer Model, Model
- Being tested
- Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDiagnostic test
Diagnostic colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Group A (Cross-sectional arm) | This group will comprise of 10,000 patients who have been referred for a colonoscopy. We will be collecting information on their past medical history, smoking history, alcohol history, medication history and family history in addition to their colonoscopy findings. In 6000 of these patients, they will have blood tests, Faecal Immunochemical Test (FIT) level, blood or saliva for DNA extraction and stool microbiome taken. In 4000 of these patients, we will record recent blood tests of interest and they will have no new samples taken. All 10000 patients will also either complete a food frequency questionnaire or endoscopy patient experience questionnaire. Receives: Diagnostic Test: Colonoscopy | |
| COLO-SPEED (Group B, consent for contact arm) | This will be 10,000 patients who will consent for future contact for future research studies. Receives: Diagnostic Test: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of colorectal neoplasia
Incidence of colorectal neoplasia (colorectal cancer and advanced adenomas)
Measured: 5 years
Secondary outcomes (2)
Stool microbiome pattern
Assessing trends in variation of stool microbiome in patients with normal colon, adenomas, bowel cancer)
Measured: 5 years
Number of participants who consent for future contact
A registry of patients who consent to be contacted in the future for future research studies
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start13 Dec 2019
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Aug 2026 (estimated)
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
- Cross-sectional
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
- Investigators
- Colin Rees, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185779
- Sponsor's protocol ID
- 1
- Status last verified
- Jun 2020
- First submitted
- 29 May 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLO-COHORT (Colorectal Cancer Cohort) Study
- ClinicalTrials.gov ID
- NCT04185779
- Acronym / sponsor ID
- 1
- Conditions
- Colorectal Cancer, Colorectal Adenoma, Colorectal Neoplasm, Predictive Cancer Model, Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 4 Dec 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.
This is a cross-sectional study aimed at identifying factors which best predicts patients at high risk of colorectal cancer or colorectal adenomas and to develop a risk prediction model.
Detailed description
Bowel cancer is the second commonest cause of cancer death in the UK with 16000 people dying per year. Although the NHS Bowel Cancer Screening Programme (BCSP) detects cancers at an earlier stage only 10% of all cancers are detected through screening.
Currently, the only criteria for screening is age and no account is taken of other known risk factors such as smoking, alcohol, family history or obesity. Stool FIT (a new stool test which detects blood that can't be seen with the naked eye) will be introduced into the English BCSP, but there is poor evidence for its use in patients presenting with symptoms. There is also emerging data that there may be differences in the gut bacteria of people with and without cancer or pre cancerous bowel polyps (adenomas).
This will be a national multi-centre study over 5-years. 10000 Patients undergoing colonoscopy as part of BCSP or due to symptoms will be recruited. Patients will be asked to fill in a health questionnaire, have their height, weight, waist circumference measured. Patients will also receive blood tests, stool tests or saliva tests depending on the indication for their colonoscopy. The results of the colonoscopy and any samples taken will be collated. Patients will receive a patient experience questionnaire or food frequency questionnaire. A further 10,000 patients from the North of England will be consented to be contacted for future studies with some of the information above collected.
The aim of this study is to develop a risk prediction model to help determine which patients are at highest risk of having adenomas or bowel cancer. The investigators will also explore the significance of the gut bacteria composition in patients with adenomas or cancer to help inform this risk model. Additionally the investigators will develop a large platform of patients who consent to be contacted for future research.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Cross-sectional arm) | – | Diagnostic Test: ColonoscopyThis group will comprise of 10,000 patients who have been referred for a colonoscopy. We will be collecting information on their past medical history, smoking history, alcohol history, medication history and family history in addition to their colonoscopy findings. In 6000 of these patients, they will have blood tests, Faecal Immunochemical Test (FIT) level, blood or saliva for DNA extraction and stool microbiome taken. In 4000 of these patients, we will record recent blood tests of interest and they will have no new samples taken. All 10000 patients will also either complete a food frequency questionnaire or endoscopy patient experience questionnaire. |
| COLO-SPEED (Group B, consent for contact arm) | – | Diagnostic Test: ColonoscopyThis will be 10,000 patients who will consent for future contact for future research studies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been referred for a colonoscopy (minimum age limits as above in inclusion criteria) either through the bowel cancer screening programme, as part of a surveillance programme or due to symptoms
Key inclusion criteria (10 listed)
- Group A
- Aged ≥30 years* and able to give informed consent
- Patients attending colonoscopy
- (COLO-SPEED) Group B
- Any patient attending for colonoscopy and able to give informed consent
Key exclusion criteria (11 listed)
- Group A
- Unable to give informed consent
- Known polyposis syndrome
- Previous total colectomy
- Known colonic stricture which would limit complete colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyDiagnostic colonoscopy | Diagnostic test | COLO-SPEED (Group B, consent for contact arm), Group A (Cross-sectional arm) |
Primary outcome
Occurrence of colorectal neoplasia
Time frame: 5 years
Incidence of colorectal neoplasia (colorectal cancer and advanced adenomas)
2 secondary outcomes
Stool microbiome pattern
Time frame: 5 years
Number of participants who consent for future contact
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- 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.
Amy Burns contact
Colin Rees principal investigator
Newcastle University
3 sites 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 and Colorectal Adenoma, run by South Tyneside and Sunderland NHS Foundation Trust at 3 sites 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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Koo (0191 404 1000, sara.koo@stft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of colorectal neoplasia (time frame: 5 years). 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 22 Oct 2020.