Liquid Biopsy MonitORing Of CholangioCarcinOma for Treatment Response and Prognostic Outcomes (MOROCCO)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Associate of PUMA levels with short term progression
研究概览
简要总结
This study explores the potential value of a new blood test approach to detect measurable residual disease or early recurrence/progression in patients with cholangiocarcinoma.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the association of PUMA levels from peripheral blood with disease progression (radiographically or clinically) in patients that are candidates for curative surgical intervention of cholangiocarcinoma.
Ia. Pre- and post-neoadjuvant-treatment PUMA levels will be associated with treatment response to neoadjuvant therapy (short term progression).
Ib. Pre-surgical and post-surgical PUMA levels will be associated with progression free survival.
II. To estimate the association of PUMA levels from peripheral blood with postoperative survival in patients treated for cholangiocarcinoma.
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 has a suspected or clinical diagnosis of cholangiocarcinoma and under evaluation for surgical intervention with intent to cure
- •Age ≥ 18 years
排除标准
- •Patient has metastatic disease involving other organs (excluding lymph node)
- •Patent has known primary cancer outside of the bile ducts within the last 3 years prior to blood collection (not including basal cell or squamous cell skin cancers, indolent cancer not requiring treatment within 3 years i.e. kidney, prostate or thyroid being observed)
- •Patient has had surgery to remove current target pathology completely or partially
- •Patient has undergone any prior radiation therapy to target lesion prior to blood collection
- •Patient has received chemotherapy class drugs in the 3 years prior to blood collection
- •Patient has had any transplants prior to blood collection
- •Current target pathology is a recurrence
研究组 & 干预措施
Observational
Patients undergo collection of blood samples and have their medical records reviewed on study. Patients also undergo collection of archived tissue samples on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Associate of PUMA levels with short term progression
时间窗: Up to 5 years
Proteins, mUtations, Methylated DNA, and Aneuploidy (PUMA) markers will be assessed pre- and post-treatment and will be associated with treatment response to therapy (short term progression; time to cholangiocarcinoma recurrence).
Associate of PUMA levels with progression free survival
时间窗: Up to 5 years
Pre-surgical and post-surgical PUMA levels will be associated with progression free survival (time to death from cholangiocarcinoma).
次要结局
未报告次要终点