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
- Diseases
- Colorectal cancer
- 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
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Regional Hospital Horsens Coordinator of this site? Confirm its status | Horsens | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Regional Hospital Randers Coordinator of this site? Confirm its status | Randers | Denmark | Unknown status |
| Regional Hospital Viborg Coordinator of this site? Confirm its status | Viborg | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.