Biobank for Validating Liquid Biopsy in Predicting the Prognosis of Superficial Colonic Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 12
- 主要终点
- Extracellular vesicles (EVs)
研究概览
简要总结
Early colorectal cancer screening increasingly detects small superficial colonic lesions, but current diagnostic tools still struggle to distinguish benign from malignant lesions and to assess lymph node risk. As histology after resection has limited accuracy, many patients undergo unnecessary surgery.
Liquid biopsy, analyzing circulating biomarkers such as tumor DNA, extracellular vesicles, and nucleosomes, offers a non-invasive way to better classify these lesions. Emerging evidence suggests it may outperform current criteria for predicting lymph node involvement in T1 colorectal cancer.
This study will establish a biobank of 1,000 patients to identify blood-based signatures that predict tumor stage and lymph node status. The hypothesis of the study is that circulating biomarkers can accurately differentiate benign from malignant lesions and identify patients with or without lymph node metastasis.
详细描述
Introduction :
Early colorectal cancer screening increasingly identifies superficial colonic lesions, but current diagnostic tools often fail to accurately distinguish benign from malignant lesions or to predict lymph node involvement. As histological criteria have limited predictive value, many patients with T1 tumors undergo unnecessary surgery. Liquid biopsy, based on circulating blood biomarkers, offers a promising non-invasive alternative that may improve diagnostic precision.
Aim :
The study aims to build a biobank of 1,000 patients with superficial colonic tumors to identify and validate circulating biomarker signatures capable of predicting tumor malignancy and lymph node status. The hypothesis is that liquid biopsy markers can reliably differentiate benign from malignant lesions and identify patients at risk of lymph node metastasis.
Methods :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient of legal age (≥ 18 years)
- •Patient with a superficial colonic tumor refered for submucosal dissection
- •Patient included in the FECCo cohort (patients will be included concomitantly in FECCO-Biobank)
- •Patient wishing to participate in the FECCO-BioBank biological collection
排除标准
- •Person with significant comorbidities preventing blood sampling
- •Patients with a distant metastasis detected by imaging
- •Person unable to read and write French
- •Person who have expressed their opposition to participating in this research after being informed by an investigator and having read the information sheet
- •Person not benefiting from a national health insurance scheme
- •Person under legal protection, guardianship or curatorship
- •Person participating in other study with an ongoing exclusion period
结局指标
主要结局
Extracellular vesicles (EVs)
时间窗: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)
Detection of plasma extracellular vesicles (EVs): * to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile) * to differentiate patients with pT1 adenocarcinoma of the colon, with lymph node metastasis (N+), from those without lymph node metastasis (N-) before treatment.
次要结局
- Circulating nucleosomes(Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor))
- Circulating tumor DNA (ctDNA)(Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor))
- Circulating proteomic profile via O-link technology(Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor))