The Diverticulitis Study

NCT06023004 | Active Not Recruiting

• 1 other identifier: The Diverticulitis study
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Colorectal Cancer; Acute Diverticulitis; Colonic Diverticulitis

Outcome Measures

Primary Outcomes (1)

• ctDNA analysis

  Blood samples will be categorized as either ctDNA positive or negative

  After recruitment of the last patient, we expect that ctDNA analyses can be performed within 6 months

Secondary Outcomes (1)

• Cost-effectiveness of treatment

  After recruitment of the last patient, we expect that cost-effectiveness analyses can be performed within 12 months

Study Arms (2)

Controls

Patients diagnosed with diverticulitis through CT scan and scheduled for a colonoscopy. The colonoscopy must result in no detection of colorectal cancer.

Cases

Patients diagnosed with CRC immediately after an episode of diverticulitis.

Eligibility Criteria

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

Study Population

Patients with newly CT-verified diverticulitis will be identified by the attending physician at the recruiting surgical departments. Patients fulfilling the inclusion criteria are approached and invited to participate.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: collaborator
• Regionshospitalet Horsens: collaborator
• University of Southern Denmark: collaborator
• Aarhus University Hospital: collaborator
• University of Aarhus: lead

Study Sites (5)

Herlev Hospital

Herlev, Capital Region of Denmark, 2730, Denmark

Location

Regional Hospital Horsens

Horsens, Central Jutland, 8700, Denmark

Location

Regional Hospital Randers

Randers, Central Jutland, 8930, Denmark

Location

Regional Hospital Viborg

Viborg, Central Jutland, 8800, Denmark

Location

Odense University Hospital

Odense, The Region of Southern Denmark, 5000, Denmark

Location

Related Publications (5)

• Andersen JC, Bundgaard L, Elbrond H, Laurberg S, Walker LR, Stovring J; Danish Surgical Society. Danish national guidelines for treatment of diverticular disease. Dan Med J. 2012 May;59(5):C4453.

  PMID: 22549495 BACKGROUND

• Meyer J, Orci LA, Combescure C, Balaphas A, Morel P, Buchs NC, Ris F. Risk of Colorectal Cancer in Patients With Acute Diverticulitis: A Systematic Review and Meta-analysis of Observational Studies. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1448-1456.e17. doi: 10.1016/j.cgh.2018.07.031. Epub 2018 Jul 26.

  PMID: 30056181 BACKGROUND

• Jensen SO, Ogaard N, Orntoft MW, Rasmussen MH, Bramsen JB, Kristensen H, Mouritzen P, Madsen MR, Madsen AH, Sunesen KG, Iversen LH, Laurberg S, Christensen IJ, Nielsen HJ, Andersen CL. Novel DNA methylation biomarkers show high sensitivity and specificity for blood-based detection of colorectal cancer-a clinical biomarker discovery and validation study. Clin Epigenetics. 2019 Nov 14;11(1):158. doi: 10.1186/s13148-019-0757-3.

  PMID: 31727158 BACKGROUND

• Jensen SO, Ogaard N, Nielsen HJ, Bramsen JB, Andersen CL. Enhanced Performance of DNA Methylation Markers by Simultaneous Measurement of Sense and Antisense DNA Strands after Cytosine Conversion. Clin Chem. 2020 Jul 1;66(7):925-933. doi: 10.1093/clinchem/hvaa100.

  PMID: 32460325 BACKGROUND

• Ogaard N, Reinert T, Henriksen TV, Frydendahl A, Aagaard E, Orntoft MW, Larsen MO, Knudsen AR, Mortensen FV, Andersen CL. Tumour-agnostic circulating tumour DNA analysis for improved recurrence surveillance after resection of colorectal liver metastases: A prospective cohort study. Eur J Cancer. 2022 Mar;163:163-176. doi: 10.1016/j.ejca.2021.12.026. Epub 2022 Jan 22.

  PMID: 35074652 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

From each patient, blood will be collected between 2 and 6 weeks after the diagnosis of diverticulitis. The blood will be collected before initiation of the bowel cleansing associated with the CRC screening colonoscopy. Blood draw: 80 mL - 7 x EDTA tubes, 1 x serum tube

MeSH Terms

Conditions

Diverticulitis, Colonic; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Bjørsum-Meyer, MD, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Per V Andersen, MD, PhD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Kåre A Gotschalck, MD, PhD

  Regionshospitalet Horsens

  PRINCIPAL INVESTIGATOR

• Liza Sopina, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion (Estimated): May 1, 2030
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

DK (5)