跳至主要内容
临床试验/NCT06023004
NCT06023004进行中(未招募)不适用

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

University of Aarhus5 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
250
试验地点
5
主要终点
ctDNA analysis

研究概览

简要总结

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.

详细描述

KEY POINTS

  • Colonoscopy is recommended after acute diverticulitis to rule out CRC, and yearly more than 2000 colonoscopies are performed.
  • CRC incidence is low in the diverticulitis population and most colonoscopies are unnecessary. It takes approximately 100-200 colonoscopies to diagnose just 1 CRC.
  • ctDNA is a minimally invasive and extraordinarily powerful biomarker of cancer.

GOALS

● To use ctDNA analysis to triage diverticulitis patients for colonoscopy. Diagnosing the same CRCs, but minimizing the number of patients needing colonoscopy

PERSPECTIVES

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

结局指标

主要结局

ctDNA analysis

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

Blood samples will be categorized as either ctDNA positive or negative

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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