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临床试验/NCT02078245
NCT02078245招募中不适用

Quality Control Study of MR Based Screening of Individual With Increased Risk for Pancreas Cancer

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
MRI accuracy

研究概览

简要总结

Early detection of pre-cancerous lesions or early stage pancreatic cancer seems to have a positive impact in survival for patients with an increased genetic risk to develop pancreas cancer.

In this study, following the indication of the swedish guidelines, consecutive patients with a family history for pancreas cancer underwent a clinical surveillance Magnetic Resonance Imaging (MRI) based. The results of this study were analyzed looking in the patients files collected during the screening period.

详细描述

Pancreatic cancer is the 4th cause of cancer related deaths in USA and in many of the Western Countries. The incidence of the disease is almost corresponding to the mortality rate. For this reason pancreatic cancer can be considered a global lethal disease. Even if treatments have improved, the resection rate in patients suffering from ductal adenocarcinoma remain around 30% and the 5 years survival rates is below 20%. Because of the low incidence of pancreatic cancer in the general population, a population-based screening is not cost/effective. Anyway in the last two decades, data from literature demonstrate that pancreatic cancer can be the phenotypic expression of some know genetic syndromes and the existence of a familial risk to develop pancreatic cancer. In particular for this last condition, called familial pancreatic cancer (FPC), an increased risk is associated with the number of family member affected. In prospective epidemiological studies, is demonstrated that a positive family history of pancreatic cancer is present in about 10% of all consecutive probands. The identification of a population at risk, the suggestions that an early surgical treatment of pancreatic cancer can improve the prognosis and, in particular, the identifications of pre-neoplastic lesions as PanIN and IPMN associated to the natural history of FPC, contributed to the development on National and International guidelines for the surveillance of the individual at increased risk. Even do, today, no consensus is reached on inclusion criteria for a clinical surveillance program, screening modalities and target lesions. Traditionally individual with a 10 fold relative risk to develop pancreatic cancer were considered suitable for a screening program. However, more recently, the CAPS group suggested to include in a surveillance program individuals with a 5 fold higher relative risk. Early pancreatic cancer, IPMN and PanIN lesions are considered the target lesions of a clinical screening, however the concrete possibility to detect PanIN lesions during a surveillance program remain debatable and uncertain.The imaging modality technique used in the existing programs are, alone or in combination, magnetic resonance (MR), computed tomography (CT), endoscopic ultrasound (EUS), endoscopic retrograde cholagiopancreatography (ERCP). Anyway a tendency to use low aggressive modalities as MR and EUS is emerging by the recent recommendations. The results of the clinical studies are quite uncertain and difficult to compare due to different screening modalities and inclusion criteria. The yield of FPC screening programs published in literature range from 50 to 1.3%. The cost/effectiveness of a surveillance program for FPC is not already demonstrated.

The aim of this study is to analyze the preliminary result of a prospective clinical surveillance program for individuals at risk for pancreatic cancer using a low aggressive, MR based, screening.

Patients enrollment Patients with an increased "genetic" risk to develop pancreatic cancer will be enrolled in a MR surveillance program at Karolinska University Hospital.

The patients were enrolled in the study from 3 different ways: relative of probands treated for pancreas cancer at karolinska University Hospital and with a positive family history of pancreatic cancer or with a positive anamnesis of an associated genetic syndrome, subjects, with a "genetically" increased risk, referred to us from other swedish centers, subjects referred to us by general partitioners.

Inclusion criteria for the screening All the individuals with a 10 fold higher relative risk in respect to the general population to develop pancreatic cancer will be included in the study. In case of suspected known genetic syndromes, only patients with detected corresponding gene mutations will be enrolled.

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • 10 fold higher risk to develop pancreatic cancer
  • Obtained informed consent

排除标准

  • age less than 18 yrs
  • No consensus obtained

结局指标

主要结局

MRI accuracy

时间窗: Three years

MRI accuracy in detection precancerous pancreatic lesions.

次要结局

  • Definition of spectrum of precancerous pancreatic lesions(During three years)
  • Outcome of surveillance program(Three years)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias Löhr

Professor

Karolinska University Hospital

研究点 (1)

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