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