DiverticulitisNCT06210724
FIT in Diverticulitis
An observational study of Diverticulitis and Colorectal Cancer, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Background and study aims Diverticular disease or diverticulosis is a benign disease of the colon. Diverticulae are pockets of bowel wall which protrude through weaknesses in the muscular wall of the colon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis, Colorectal Cancer
- What is being tested?
- Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiome
- How many people
- 275 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2023to 28 Oct 2024
- 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 attending hospital with a radiological diagnosis of acute diverticulitis
Who may be able to join
- Computerised tomography diagnosis of acute diverticulitis
- Participants capable of giving informed consent
- Aged ≥ 18 years
- Clinical decision for colonoscopy, flexible sigmoidoscopy or CT colonoscopy follow-up after diverticulitis diagnosis
Who cannot join
- Paediatric patients (<18 years)
- Not provided at least 1 faecal sample
- Unable to/unwilling to provide informed consent
- Withdrawal of consent for inclusion in study
- Previous pan-proctocolectomy, subtotal colectomy surgery, or presence of stoma
- Currently being treated for colorectal cancer
Show all 9Show fewer
- Mental health illness limiting compliance
- Treated in hospital with colonic resection
- Did not have colonoscopy, flexible sigmoidoscopy or CT colonoscopy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
James Norman, BSci, BMBS, MRCS, +44 (0) 1483 688691, j.norman1@nhs.net
Laura Gordon, +44 (0) 1483686729, laura.gordon2@nhs.net
About this study
Official title: Use of Faecal Biomarkers After Acute Diverticulitis: Can They Risk Stratify for Colorectal Cancer?
Background and study aims
Diverticular disease or diverticulosis is a benign disease of the colon. Diverticulae are pockets of bowel wall which protrude through weaknesses in the muscular wall of the colon. The mechanisms leading to their formation remains unclear and is likely a complex interaction of multiple factors. For the majority of people these pockets are incidental findings they can become inflamed which is called diverticulitis.
Read more
The main aim of this study is to see if a faecal samples, which will be tested for hidden blood content with a faecal immunochemical test for haemoglobin (FIT), could be used as an alternative to currently used follow-up investigations for patients who have an episode of acute diverticulitis confirmed on a computerised tomography (CT) scan. These are colonoscopy, sigmoidoscopy or a special CT called CT colonoscopy.
The investigators will also be testing faecal calprotectin which is a marker of bowel inflammation and an assessment of the microbes that live in the bowel to see if this will provide further insights into the diagnosis and treatment of diverticulitis.
Who can participate?
All patients 18 or over admitted to a participating hospital with acute diverticulitis confirmed on a CT scan and who planned to have one of the currently used follow-up investigations are eligible.
What does the study involve?
The study will involve participants taking three stool (faecal) samples using faecal testing kits posted to participants. One is as close to their first solid stool after diagnosis as possible, the others are at 3 weeks after diagnosis and then 6 weeks after diagnosis.
What are the possible benefits and risks of participating?
There are no risks of participating. The investigators hope to demonstrate that a negative FIT test for patients after acute diverticulitis will be able to exclude a bowel cancer and prevent the majority of future patients having invasive and time consuming tests. There no additional benefit for participants for their current episode, as they will still need to have these tests.
Where is the study run from?
Royal Surrey County Hospital
When is the study starting and how long is it expected to run for?
09/10/2023-30/09/2024
Who is funding the study?
The study is being funded by MATTU (Minimal Access Therapy Training Unit), GUTS (GUTS - Fighting Bowel Cancer) and NHIR (National Institute for Health and Care Research).
Who is the main contact?
James Norman, On the study email rsch.colorectalDfitstudy@nhs.net
Read the detailed description
What is the purpose of the study?
The main aim of this study is to see if a faecal immunochemical test (FIT), could be used as an alternative to currently used follow-up investigations, of colonoscopy, flexible sigmoidoscopy or CT (computerised tomography) colonography, for patients who have an episode of acute diverticulitis to exclude a colorectal cancer (CRC). As stated in the ASCPGBI consensus guidelines 2021 the risk of CRC in those with CT diagnosed uncomplicated diverticulitis is 1.6-1.9% and in those with complicated diverticulitis 7.8-10.9%.
Our primary aim is to determine whether single, or multiple faecal haemoglobin and faecal calprotectin results after an episode of acute diverticulitis can be used to risk stratify for further investigations to exclude colorectal cancer.
Our secondary aims are:
To determine whether single, or multiple faecal haemoglobin and faecal calprotectin results after an episode of acute diverticulitis could be used to risk stratify for further investigations to exclude other colonic findings such as high-risk adenoma?
Would including demographic factors such as age or anaemia allow better risk stratification?
Assess the faecal microbiome in patients with acute diverticulitis and how it changes as inflammation settles.
Any antibiotic treatment will also be recorded and the effect on the faecal microbiome analysed.
Inclusion criteria:
Computerised tomography diagnosis of acute diverticulitis Participants capable of giving informed consent Aged ≥ 18 years Planned for colonoscopy, flexible sigmoidoscopy or CT colonoscopy after diverticulitis diagnosis
Exclusion criteria:
Paediatric patients (<18 years) Not provided at least 1 FIT sample Unable to/unwilling to provide informed consent Withdrawal of consent for inclusion in study Previous pan-proctocolectomy, subtotal colectomy surgery, or presence of stoma Diagnosed with colorectal cancer Mental health illness limiting compliance Treated in hospital with colonic resection Did not have colonoscopy, flexible sigmoidoscopy or CT colonoscopy
Recruitment:
Patients who attend hospital with a diagnosis of acute diverticulitis confirmed on a CT scan and who have had a clinical decision to follow-up with either a colonoscopy, flexible sigmoidoscopy or CT colonography will be approached for written consent to participate.
Patients will then be posted a patient information leaflet and a pack with collection devices to take samples at home and post back. The results of their follow-up investigation (colonoscopy, flexible sigmoidoscopy or CT colonography + any histology) will be collected when completed
Involvement for patients will involve collecting and posting back in pre-paid envelopes faecal samples on their first solid stool (or as soon as possible after diagnosis) and at 3 and 6 weeks post-diagnosis.
Sample size: 275 - Estimated using available data on diverticulitis and stratified data from FIT use in 2WW patients.
- Conditions
- Diverticulitis, Colorectal Cancer
- Being tested
- Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiome
- Keywords
- Faecal Immunochemical test for haemoglobin, FIT, Faecal calprotectin, Faecal microbiome
- Medical subject headings
- Diverticulitis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiomeDiagnostic test
Faecal samples to be collected by patients at home and delivered via post to a bowel cancer screening hub for analysis
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | In addition to standard of care, three faecal samples will be obtained. On as soon as possible after diagnosis, one at three weeks post diagnosis and one at six. Receives: Diagnostic Test: Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer
Diagnosis or absence of colorectal cancer on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Measured: Dependant on timing of investigation but expected 6-12 weeks
Secondary outcomes (5)
High risk adenoma
Diagnosis or absence of high risk adenoma on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Measured: Dependant on timing of investigation but expected 6-12 weeks
Diverticulitis
Diagnosis or absence of ongoing diverticular inflammation on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Measured: Dependant on timing of investigation but expected 6-12 weeks
Perianal disease
Diagnosis or absence of perianal disease on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Measured: Dependant on timing of investigation but expected 6-12 weeks
Inflammatory bowel disease
Diagnosis or absence of inflammatory bowel disease on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Measured: Dependant on timing of investigation but expected 6-12 weeks
Microscopic colitis
Diagnosis or absence of microscopic colitis on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
Measured: Dependant on timing of investigation but expected 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start9 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion28 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies 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
- Prospective
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- GUTS - Fighting Bowel Cancer, Minimal Access Therapy Training Unit
- Responsible party
- Sponsor
- Investigators
- Sally Benton, FRCPath, Study director, Royal Surrey NHS foundation trustJames Norman, BMBS, MRCP, Principal investigator, Royal Surrey NHS foundation trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210724
- Sponsor's protocol ID
- 55623
- Other IDs
- 323724, 55623
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be anonymised before analysis and before any data is shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Faecal Biomarkers After Acute Diverticulitis: Can They Risk Stratify for Colorectal Cancer?
- ClinicalTrials.gov ID
- NCT06210724
- Acronym / sponsor ID
- 55623
- Conditions
- Diverticulitis, Colorectal Cancer
- Keywords
- Faecal Immunochemical test for haemoglobin, FIT, Faecal calprotectin, Faecal microbiome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- GUTS - Fighting Bowel Cancer, Minimal Access Therapy Training Unit
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 28 Oct 2024 (estimated)
- First posted
- 18 Jan 2024 (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.
Background and study aims
Diverticular disease or diverticulosis is a benign disease of the colon. Diverticulae are pockets of bowel wall which protrude through weaknesses in the muscular wall of the colon. The mechanisms leading to their formation remains unclear and is likely a complex interaction of multiple factors. For the majority of people these pockets are incidental findings they can become inflamed which is called diverticulitis.
The main aim of this study is to see if a faecal samples, which will be tested for hidden blood content with a faecal immunochemical test for haemoglobin (FIT), could be used as an alternative to currently used follow-up investigations for patients who have an episode of acute diverticulitis confirmed on a computerised tomography (CT) scan. These are colonoscopy, sigmoidoscopy or a special CT called CT colonoscopy.
The investigators will also be testing faecal calprotectin which is a marker of bowel inflammation and an assessment of the microbes that live in the bowel to see if this will provide further insights into the diagnosis and treatment of diverticulitis.
Who can participate?
All patients 18 or over admitted to a participating hospital with acute diverticulitis confirmed on a CT scan and who planned to have one of the currently used follow-up investigations are eligible.
What does the study involve?
The study will involve participants taking three stool (faecal) samples using faecal testing kits posted to participants. One is as close to their first solid stool after diagnosis as possible, the others are at 3 weeks after diagnosis and then 6 weeks after diagnosis.
What are the possible benefits and risks of participating?
There are no risks of participating. The investigators hope to demonstrate that a negative FIT test for patients after acute diverticulitis will be able to exclude a bowel cancer and prevent the majority of future patients having invasive and time consuming tests. There no additional benefit for participants for their current episode, as they will still need to have these tests.
Where is the study run from?
Royal Surrey County Hospital
When is the study starting and how long is it expected to run for?
09/10/2023-30/09/2024
Who is funding the study?
The study is being funded by MATTU (Minimal Access Therapy Training Unit), GUTS (GUTS - Fighting Bowel Cancer) and NHIR (National Institute for Health and Care Research).
Who is the main contact?
James Norman, On the study email rsch.colorectalDfitstudy@nhs.net
Detailed description
What is the purpose of the study?
The main aim of this study is to see if a faecal immunochemical test (FIT), could be used as an alternative to currently used follow-up investigations, of colonoscopy, flexible sigmoidoscopy or CT (computerised tomography) colonography, for patients who have an episode of acute diverticulitis to exclude a colorectal cancer (CRC). As stated in the ASCPGBI consensus guidelines 2021 the risk of CRC in those with CT diagnosed uncomplicated diverticulitis is 1.6-1.9% and in those with complicated diverticulitis 7.8-10.9%.
Our primary aim is to determine whether single, or multiple faecal haemoglobin and faecal calprotectin results after an episode of acute diverticulitis can be used to risk stratify for further investigations to exclude colorectal cancer.
Our secondary aims are:
To determine whether single, or multiple faecal haemoglobin and faecal calprotectin results after an episode of acute diverticulitis could be used to risk stratify for further investigations to exclude other colonic findings such as high-risk adenoma?
Would including demographic factors such as age or anaemia allow better risk stratification?
Assess the faecal microbiome in patients with acute diverticulitis and how it changes as inflammation settles.
Any antibiotic treatment will also be recorded and the effect on the faecal microbiome analysed.
Inclusion criteria:
Computerised tomography diagnosis of acute diverticulitis Participants capable of giving informed consent Aged ≥ 18 years Planned for colonoscopy, flexible sigmoidoscopy or CT colonoscopy after diverticulitis diagnosis
Exclusion criteria:
Paediatric patients (<18 years) Not provided at least 1 FIT sample Unable to/unwilling to provide informed consent Withdrawal of consent for inclusion in study Previous pan-proctocolectomy, subtotal colectomy surgery, or presence of stoma Diagnosed with colorectal cancer Mental health illness limiting compliance Treated in hospital with colonic resection Did not have colonoscopy, flexible sigmoidoscopy or CT colonoscopy
Recruitment:
Patients who attend hospital with a diagnosis of acute diverticulitis confirmed on a CT scan and who have had a clinical decision to follow-up with either a colonoscopy, flexible sigmoidoscopy or CT colonography will be approached for written consent to participate.
Patients will then be posted a patient information leaflet and a pack with collection devices to take samples at home and post back. The results of their follow-up investigation (colonoscopy, flexible sigmoidoscopy or CT colonography + any histology) will be collected when completed
Involvement for patients will involve collecting and posting back in pre-paid envelopes faecal samples on their first solid stool (or as soon as possible after diagnosis) and at 3 and 6 weeks post-diagnosis.
Sample size: 275 - Estimated using available data on diverticulitis and stratified data from FIT use in 2WW patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Diagnostic Test: Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiomeIn addition to standard of care, three faecal samples will be obtained. On as soon as possible after diagnosis, one at three weeks post diagnosis and one at six. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending hospital with a radiological diagnosis of acute diverticulitis
Key inclusion criteria (4 listed)
- Computerised tomography diagnosis of acute diverticulitis
- Participants capable of giving informed consent
- Aged ≥ 18 years
- Clinical decision for colonoscopy, flexible sigmoidoscopy or CT colonoscopy follow-up after diverticulitis diagnosis
Key exclusion criteria (9 listed)
- Paediatric patients (<18 years)
- Not provided at least 1 faecal sample
- Unable to/unwilling to provide informed consent
- Withdrawal of consent for inclusion in study
- Previous pan-proctocolectomy, subtotal colectomy surgery, or presence of stoma
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 |
|---|---|---|
| Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiomeFaecal samples to be collected by patients at home and delivered via post to a bowel cancer screening hub for analysis | Diagnostic test | Study cohort |
Primary outcome
Colorectal Cancer
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Diagnosis or absence of colorectal cancer on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.
5 secondary outcomes
High risk adenoma
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Diverticulitis
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Perianal disease
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Inflammatory bowel disease
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Microscopic colitis
Time frame: Dependant on timing of investigation but expected 6-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. All data will be anonymised before analysis and before any data is shared with other researchers
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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.
Sally Benton, FRCPath study director
Royal Surrey NHS foundation trust
James Norman, BMBS, MRCP principal investigator
Royal Surrey NHS foundation trust
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 Diverticulitis and Colorectal Cancer, run by Royal Surrey County Hospital NHS Foundation Trust 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 4 inclusion and 9 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 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Norman, BMBS, MRCP (+44 (0) 1483 688691, j.norman1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal Cancer (time frame: Dependant on timing of investigation but expected 6-12 weeks). 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 19 Sep 2024.