The PREPAIRD Study: Personalized suRveillance for Early Detection and Prevention of Pancreatic cAncer in High Risk inDividuals
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prognosis of pancreatic cancer in patients diagnosed through the surveillance programme compared to prognosis in unscreened individuals as reported to the Cancer Registry of Norway.
研究概览
简要总结
The objective of this national and multidisciplinary project is to establish and evaluate a personalized surveillance program (SP) for early diagnosis of pancreatic cancer (PC) and its precursors in individuals with a hereditary predisposition to the disease (High RIsk Individuals (HRI)). Patients who either carry a germline mutation in a PC susceptibility gene (CDKN2A, STK11, TP53, PRSS1), or have a strong family history of PC, will be enrolled through their genetics clinic at the university hospitals in Oslo, Bergen, Trondheim and Tromsø. Surveillance consists of annual MRI, assessment of blood glucose and lipid levels, new onset diabetes (NOD) and unintentional weight loss. Blood samples will be drawn for ctDNA-analysis (circulating tumor DNA) and the IMMrayTM PanCan-d test (a novel microarray-based diagnostic test for PC) at baseline and in those who develop lesions. The psychological burden and cost-benefit of the SP will be analyzed. The study addresses an unmet need for the care of HRI in Norway, and is expected to improve PC prognosis. It will be the first to provide evidence on the combined value of a panel of blood-borne biomarkers in surveillance, and provide morphological and molecular data on PC and (non)-neoplastic pancreatic changes in HRI.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women with a germline mutation in CDKN2A, TP53, PRSS1 or STK11
- •Men or women who are first degree relatives to a patient with pancreatic cancer (PC) in a family with Familial Pancreatic Cancer (FPC).
排除标准
- •Patients undergoing active cancer treatment.
结局指标
主要结局
Prognosis of pancreatic cancer in patients diagnosed through the surveillance programme compared to prognosis in unscreened individuals as reported to the Cancer Registry of Norway.
时间窗: Up to 20 years
We will investigate whether 3 year, 5 year and long term survival in HRIs undergoing surveillance is improved compared to rates of survival of pancreatic cancer in the general unscreened population. Survival data for the general population will be collected from the Cancer Registry of Norway. Data on prognosis of pancreatic cancer in patients undergoing surveillance will be collected from electronic patient records, The Cancer Registry of Norway and the National Population Register.
Number of resectable cancers detected in patients diagnosed through the surveillance programme compared to the unscreened individuals as reported to the Cancer Registry of Norway.
时间窗: 20 years
We will investigate whether the number of surgically resectable cancers is higher in HRIs undergoing screening through the surveillance programme compared to pancreatic cancer diagnosed in the general population of Norway. Data on number of resectable cancers in the general Norwegian population will be collected from the Cancer Registry of Norway. Data on cancers diagnosed in the HRI will be collected from electronic patient records and The Cancer Registry of Norway.
次要结局
- Quality of life of participants undergoing surveillance as assessed with the Hospital Anxiety and Depression Scale (HADS)(10 years)
- Costs(Up to 20 years)
- Cost-effectiveness analysis(Up to 20 years)
- The general health of participants undergoing surveillance as assessed by the Genereal Health questionnaire(10 years)
- The general health of participants undergoing surveillance as assessed with the General Health Questionnaire(10 years)
- The psychological well-being of participants undergoing surveillance as assessed by the Psychological Well-being Questionnaire(10 years)
- Healthcare utilization(20 years)
- The psychological consequences of undergoing screening for pancreatic cancer as assessed by the Psychological Consequences of Screening questionnaire(10 years)
- Quality of life of participants undergoing surveillance as assessed with the Impact of Event Scale (IES)(10 years)
- The cancer worry of participants undergoing surveillance as assessed with the Cancer Worry Scale(10 years)
研究者
Eli Marie Grindedal
Head of Section for Hereditary Cancer
Oslo University Hospital