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NCT06023004Active, not recruiting

The Diverticulitis Study

Circulating Tumor DNA Guided vs Opportunistic Colonoscopy Screening for CRC Detection After Acute Colonic Diverticulitis - the Diverticulitis Study

Source: ClinicalTrials.gov · Last updated 6 Feb 2026

Brief summary (registry, in English)

Acute colonic diverticulitis is when a part of the colon gets swollen and inflamed. The diagnosis is based on a CT scan, which can show thickening of the colonic walls and infiltration of the diverticula. These changes and the concomitant symptoms can overlap with colorectal cancer (CRC). Therefore, the guidelines suggest that people with diverticulitis should be offered a colonoscopy to ensure, that CRC is not the underlying cause of the changes and symptoms. In Denmark, a lot of people get hospitalized each year due to diverticulitis, and many of them end up having colonoscopies with the purpose of excluding CRC. Currently, there are no methods for guiding colonoscopies following a diverticulitis episode, resulting in numerous unnecessary colonoscopies each year. In the Diverticulitis study, we want to investigate if a simple blood test analyzed for the presence of circulating tumor DNA (ctDNA), can help us decide who needs a colonoscopy. We will collect blood samples from 220 people with diverticulitis and categorize them into ctDNA positive and negative groups. The ctDNA category will be compared to the colonoscopy results to see if there is a correlation between being ctDNA positive and having a CRC diagnosed at the colonoscopy. This study could change clinical practice since we anticipate that ctDNA-guided triaging of diverticulitis patients is a cost-effective strategy for selecting diverticulitis patients needing colonoscopy, ensuring detection of the underlying CRC, and significantly reducing the number of patients undergoing unnecessary colonoscopy.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
28 Aug 2023
Start date
1 May 2022
Primary completion date
1 May 2024
Lead sponsor
University of Aarhus
NCT number
NCT06023004

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 1 May 2022 to the primary completion date, 1 May 2024
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Unable to provide oral and written informed consent
  • Recent colonic imaging and no need for renewed visualization of the colonic mucosa deemed by the attending doctor

Who the study is looking for

  • CT-verified diverticulitis eligible for a follow-up colonoscopy

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Herlev Hospital
Coordinator of this site? Confirm its status
HerlevDenmarkUnknown status
Regional Hospital Horsens
Coordinator of this site? Confirm its status
HorsensDenmarkUnknown status
Odense University Hospital
Coordinator of this site? Confirm its status
OdenseDenmarkUnknown status
Regional Hospital Randers
Coordinator of this site? Confirm its status
RandersDenmarkUnknown status
Regional Hospital Viborg
Coordinator of this site? Confirm its status
ViborgDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.