Colorectal Cancer Clinical Trial
Official title:
Circulating Tumor DNA Guided vs Opportunistic Colonoscopy Screening for CRC Detection After Acute Colonic Diverticulitis - the Diverticulitis Study
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 | Recruiting |
Enrollment | 250 |
Est. completion date | May 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - CT-verified diverticulitis eligible for a follow-up colonoscopy Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev Hospital | Herlev | Capital Region Of Denmark |
Denmark | Regional Hospital Horsens | Horsens | Central Denmark Region |
Denmark | Odense University Hospital | Odense | The Region Of Southern Denmark |
Denmark | Regional Hospital Randers | Randers | Central Denmark Region |
Denmark | Regional Hospital Viborg | Viborg | Central Denmark Region |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Odense University Hospital, Regional Hospital Horsens, University of Southern Denmark |
Denmark,
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Cost-effectiveness of treatment | Assessment of the cost-effectiveness of "ctDNA guided" versus "opportunistic" colonoscopy screening of the diverticulitis patients | After recruitment of the last patient, we expect that cost-effectiveness analyses can be performed within 12 months |
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