Precision-Panc Master Protocol: Personalising Treatment For Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 33
- 主要终点
- Proving that patients with pancreatic cancer can have their tissue molecularly assessed and be followed up in a clinical trial setting
研究概览
简要总结
The Precision-Panc Master Protocol is a "portal" protocol for patients with known or suspected pancreatic cancer to be accrued through multiple centres in the UK, with the option of being subsequently enrolled into PRIMUS (Pancreatic canceR Individualised Multi-arm Umbrella Studies) examining different treatment regimens and/or biomarker development. Eligible patients will undergo tumour biopsy and blood collection prospectively for molecular profiling at a central laboratory and the results may be used to inform enrolment to PRIMUS studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age >16 years).
- •Presence of a hypodense pancreatic mass highly suspicious of primary pancreatic cancer with or without distant metastasis as assessed by a Pancreatic Multi-Disciplinary Team (MDT).
- •o Histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants.
- •Patient is willing and able to undergo additional tumour biopsy (from the primary or a metastatic site) aimed at obtaining sufficient tissue for molecular profiling if this is required.
- •Patient is deemed suitable to receive chemotherapy and/or radiotherapy, and/or surgery pending stage of disease at presentation.
- •Patient is deemed potentially eligible for a currently open PRIMUS study
- •Patient has signed informed consent for screening research tumour biopsy (Consent 1).
- •Patient has signed informed consent for Precision-Panc Master Protocol molecular profiling (Consent 2).
排除标准
- 未提供
结局指标
主要结局
Proving that patients with pancreatic cancer can have their tissue molecularly assessed and be followed up in a clinical trial setting
时间窗: At end of study (5 years)
The number of patients screened and registered to the master protocol will be recorded. The number of patients who we are able to molecular assess will be recorded and all patients will be followed up in the master protocol until death.
次要结局
- Number of participants with biopsy related adverse events as assesed by CTCAE v4.03(At time of biopsy, usually within one week of screening)
- Overall Survival(From date of registration until date of death from any cause, assessed up to 5 years)
研究者
Judith Dixon-Hughes
Project Manager
University of Glasgow