Liquid Biopsy Using Exosomal miRNA for Intrahepatic Cholangiocarcinoma Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 535
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
Intrahepatic cholangiocarcinoma (ICC) is a malignant liver tumor with poor prognosis and limited curative treatment options. Early and accurate detection remains an unmet clinical need.
The LUMIC study aims to develop a non-invasive liquid biopsy platform based on both exosomal microRNAs (exo-miRNAs) to detect intrahepatic cholangiocarcinoma with high sensitivity and specificity.
详细描述
Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver malignancy after hepatocellular carcinoma, accounting for approximately 10-15% of all primary liver cancers. Despite improvements in surgical techniques and imaging modalities, ICC is often diagnosed at advanced stages, resulting in dismal outcomes with a 5-year overall survival rate of 25-30%.
Traditional imaging approaches such as CT and MRI have limited sensitivity for detecting early or small ICC lesions. Blood-based biomarkers, including CA19-9, also lack adequate specificity.
Recent advances in liquid biopsy have demonstrated that exosomal microRNAs (exo-miRNAs) can serve as promising, minimally invasive biomarkers reflecting tumor biology and microenvironmental changes.
The LUMIC study (Liquid biopsy Using exosomal miRNA for Intrahepatic Cholangiocarcinoma detection) aims to identify and validate miRNA signatures capable of distinguishing ICC from benign biliary or non-cancerous liver conditions.
Blood samples are collected before treatment, and exo-miRNA expression profiles are analyzed using RT-qPCR and bioinformatic pipelines. Diagnostic performance (AUC, sensitivity, specificity) will be evaluated through training and validation cohorts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Histologically confirmed intrahepatic cholangiocarcinoma
- •Availability of pre-treatment plasma sample
- •Informed consent provided
排除标准
- •Extrahepatic cholangiocarcinoma
- •History of other malignancy within 5 years
- •Active infection, autoimmune disease, or pregnancy
- •Inadequate clinical data or poor sample quality
研究组 & 干预措施
Intrahepatic Cholangiocarcinoma (Discovery, Small RNA-seq)
Serum and plasma samples from patients with histologically confirmed ICC will be analyzed using small RNA sequencing to identify circulating miRNAs specifically upregulated in ICC. These miRNAs will serve as candidates for downstream validation.
干预措施: Small RNA sequencing (Diagnostic Test)
Non-disease Control (Discovery, Small RNA-seq)
Serum and plasma samples from individuals without malignant or inflammatory liver diseases (benign or healthy controls) will be analyzed in parallel by small RNA sequencing to identify miRNAs differentially expressed between ICC and non-disease controls.
干预措施: Small RNA sequencing (Diagnostic Test)
Intrahepatic Cholangiocarcinoma (Training)
Patients with histologically confirmed ICC whose pre-treatment serum or plasma samples will be used to construct and optimize the exo-miRNA diagnostic panel based on discovery-phase candidates.
干预措施: LUMIC assay (Diagnostic Test)
Non-disease Control (Training)
Individuals without malignant or inflammatory liver diseases (benign or healthy controls) whose serum/plasma samples will serve as controls to establish baseline miRNA expression and diagnostic thresholds.
干预措施: LUMIC assay (Diagnostic Test)
Intrahepatic Cholangiocarcinoma (Validation)
Independent ICC cohort used for external validation of the LUMIC assay to confirm diagnostic performance and reproducibility.
干预措施: LUMIC assay (Diagnostic Test)
Non-disease Control (Validation)
Individuals without malignant or inflammatory liver diseases (benign or healthy controls) whose serum/plasma samples will be used for validation of specificity and model robustness.
干预措施: LUMIC assay (Diagnostic Test)
结局指标
主要结局
Sensitivity
时间窗: Through study completion (~1 year)
The proportion of true positive ICC cases correctly identified by the LUMIC assay.
次要结局
- Specificity(Through study completion (~1 year))
- Diagnostic accuracy (AUC)(Through study completion (~1 year))