Development and Validation of a Circulating Tumour DNA Marker for Pre-neoplastic Colorectal Tumours.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Pre-resection ctDNA Detection Rate
研究概览
简要总结
The goal of this prospective interventional biomarker development and validation study is to determine whether circulating tumour DNA (ctDNA) can be detected in patients with large pre-neoplastic colorectal lesions undergoing endoscopic resection and whether ctDNA can be used to identify local recurrence after resection.
The main questions it aims to answer are:
- Can advanced colorectal laterally spreading tumours (LSTs) shed detectable ctDNA into the bloodstream before endoscopic resection?
- Can ctDNA measured at the first surveillance colonoscopy detect or predict local recurrence after endoscopic resection?
Participants will:
- Provide a blood sample before their planned endoscopic resection procedure for ctDNA analysis.
- Undergo standard endoscopic resection of their colorectal lesion.
- Allow collection and molecular analysis of tissue samples obtained from the resected lesion.
- Allow researchers to collect clinical, endoscopic, pathological, and molecular data from their medical records for research purposes.
The study does not alter the standard clinical management, resection technique, or surveillance schedule. The only study-specific procedures are blood sample collections performed during routine intravenous catheter placement for the participant's endoscopic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥ 18 years.
- •Referred for resection of a large (≥ 10 mm) colorectal laterally spreading tumour (LST).
- •Lesion judged amenable to endoscopic resection by the treating endoscopist.
- •Able to provide written informed consent.
排除标准
- •Known concurrent or prior colorectal cancer, or another active malignancy that could contribute circulating tumour DNA.
- •Lesion < 10 mm.
- •Inability to provide informed consent.
结局指标
主要结局
Pre-resection ctDNA Detection Rate
时间窗: Baseline
Detection of circulating tumour DNA (ctDNA) in the pre-resection plasma sample using a tumour-informed assay. A positive result is defined according to the prespecified threshold for detected tumour-specific variants. The primary outcome is the proportion of evaluable lesions with detectable ctDNA prior to endoscopic resection.
次要结局
- Local recurrence according to pre-resection ctDNA status(6 months)
- Quantitative pre-resection ctDNA signal(Baseline)
- ctDNA detection rate by lesion characteristics(Baseline)