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临床试验/NCT05117723
NCT05117723招募中不适用

Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer

St Vincent's Hospital Melbourne1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
The proportion of patients who have progressed to further investigations including endoscopic ultrasound (EUS) and/or surgical intervention.

研究概览

简要总结

Pancreatic cancer is the 5th leading cause of cancer death in Australia. Surgery remains the most effective treatment for early pancreatic cancer and currently the only potential for cure. Unfortunately, many patients present with advanced disease and are not suitable for surgery. Therefore, it is vital to detect these cancers early. In the absence of significant data from prospective studies, all of the guidelines are based on a critical review of available data and consensus of experts. The primary aim is to delineate the progression of IPMN to pancreatic malignancy as confirmed by surgical pathology, radiology and biochemical diagnosis. The secondary aims are (i) To outline the management of IPMNs for those who have progressed straight to surgery or surveillance by endoscopic ultrasound (EUS) (ii)To validate the International consensus guidelines for management of IPMN - Fukuoka consensus guidelines and tertiary aim to identify potential risk factors, if any that increase risk of malignancy within the IPMNs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients between the age of 18 and 90 years old who have been identified with a cystic mass consistent with IPMN on imaging

排除标准

  • Patients who formally decline enrolment into the study

结局指标

主要结局

The proportion of patients who have progressed to further investigations including endoscopic ultrasound (EUS) and/or surgical intervention.

时间窗: From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years

Risk stratification for patients with IPMN into those that require more intensive screening and possibly intervention versus those that are unlikely to progress to malignancy.

时间窗: From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years

次要结局

未报告次要终点

研究者

发起方
St Vincent's Hospital Melbourne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Fox

Principal Investigator

St Vincent's Hospital Melbourne

研究点 (1)

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