Detection, Treatment and Survival of Pancreatic Cancer Recurrence in the Netherlands
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 1,750
- 试验地点
- 1
- 主要终点
- Incidence of PDAC recurrence
研究概览
简要总结
The aim of this nationwide, observational cohort study is to evaluate current surveillance strategies after primary resection of pancreatic ductal adenocarcinoma (PDAC) in the Netherlands, with regard to the detection, treatment and survival of PDAC recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a pancreatic resection (PPPD, Whipple, distal pancreatectomy or total pancreatectomy) for histologically proven PDAC in one of the 16 Dutch centers for pancreatic surgery
排除标准
- •Patients with 30-day postoperative mortality
结局指标
主要结局
Incidence of PDAC recurrence
时间窗: Within a follow-up period up to 5 years
Incidence of PDAC recurrence within the Netherlands; PDAC recurrence is either pathologically proven, or suspected through cross-sectional imaging, preferably confirmed by consensus during a multidisciplinary meeting.
Patterns of PDAC recurrence
时间窗: Within a follow-up period up to 5 years
* Asymptomatic vs. symptomatic: Symptomatic recurrence is defined as the presence of symptoms suggestive for PDAC recurrence at recurrence diagnosis. If PDAC recurrence is detected in absence of suspected symptoms, disease recurrence was defined as asymptomatic. * First site of recurrence: isolated local recurrence, liver-only, lung-only, multiple-site, other isolated distant * Early vs. late recurrence: disease-free survival ≥12 months vs. \<12 months
Survival
时间窗: Within a follow-up period up to 5 years
Overall survival (from the time of resection), disease-free survival (from the time of resection), post-recurrence survival (from the time of recurrence diagnosis)
Treatment of PDAC recurrence
时间窗: Within a follow-up period up to 5 years
Either systemic and/or local treatment or best-supportive-care
次要结局
- Number of histologically confirmed recurrences(Within a follow-up period up to 5 years)
- Performance score at time of recurrence detection(Within a follow-up period up to 5 years)
- Presence of symptoms at time of (suspected) recurrence(Within a follow-up period up to 5 years)
- Use of imaging procedures during follow-up(Within a follow-up period up to 5 years)
研究者
Prof. dr. I.Q. Molenaar, MD, PhD
Prof. dr.
UMC Utrecht