FIT in Diverticulitis

NCT06210724 | Unknown

• 2 other identifiers: 55623323724
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Diverticulitis; Colorectal Cancer

Keywords

Faecal Immunochemical test for haemoglobin; FIT; Faecal calprotectin; Faecal microbiome

Outcome Measures

Primary Outcomes (1)

• Colorectal Cancer

  Diagnosis or absence of colorectal cancer on follow-up investigation (Colonoscopy, flexible sigmoidoscopy or CT colonography)and subsequent histology results if applicable.

  Dependant on timing of investigation but expected 6-12 weeks

Secondary Outcomes (5)

• High risk adenoma

  Dependant on timing of investigation but expected 6-12 weeks

• Diverticulitis

  Dependant on timing of investigation but expected 6-12 weeks

• Perianal disease

  Dependant on timing of investigation but expected 6-12 weeks

• Inflammatory bowel disease

  Dependant on timing of investigation but expected 6-12 weeks

• Microscopic colitis

  Dependant on timing of investigation but expected 6-12 weeks

Other Outcomes (4)

• FIT (Faecal Immunochemical Test for haemoglobin) test result

  6 weeks

• Faecal calprotectin test result

  6 weeks

• Faecal microbiome

  6 weeks

Study Arms (1)

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.

Diagnostic Test: Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiome

Interventions

Faecal immunochemical test for haemoglobin, faecal calprotectin, faecal microbiome DIAGNOSTIC_TEST

Faecal samples to be collected by patients at home and delivered via post to a bowel cancer screening hub for analysis

Study cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients attending hospital with a radiological diagnosis of acute diverticulitis

You may qualify if:

• 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

You may not qualify if:

• Paediatric patients (\<18 years)
• Not provided at least 1 faecal sample
• Unable to/unwilling to provide informed consent
• Previous pan-proctocolectomy, subtotal colectomy surgery, or presence of stoma
• Currently being treated for colorectal cancer
• Mental health illness limiting compliance
• Treated in hospital with colonic resection
• Did not have colonoscopy, flexible sigmoidoscopy or CT colonoscopy

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead
• GUTS - Fighting Bowel Cancer: collaborator
• Minimal Access Therapy Training Unit: collaborator

Study Sites (1)

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diverticulitis; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sally Benton, FRCPath

  Royal Surrey NHS foundation trust

  STUDY DIRECTOR

• James Norman, BMBS, MRCP

  Royal Surrey NHS foundation trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Norman, BMBS, MRCP

CONTACT

+44 (0) 1483 688691; j.norman1@nhs.net

Laura Gordon

CONTACT

+44 (0)1483686729; laura.gordon2@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: October 9, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)