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临床试验/NCT01104077
NCT01104077已完成不适用

Family and Personal History of Pancreatic and Other Malignancies in Patients With Intraductal Papillary Mucinous Neoplasms

Columbia University1 个研究点 分布在 1 个国家目标入组 277 人开始时间: 2008年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
277
试验地点
1
主要终点
Percentage of IPMN patients with relatives with pancreatic cancer or IPMN

研究概览

简要总结

This is a retrospective observational study to determine the proportion of patients with a family history of pancreatic cancer and other malignancies among patients who have intraductal papillary mucinous neoplasm (IPMN).

The investigators will be reviewing the demographic, clinical, radiologic, pathologic, and follow-up information from the Pancres Center database. The investigators will also conduct a chart review to collect information recorded by clinicians on each subject's family history of malignancy and personal history of malignancy. Results of this database and chart review will be incorporated into a datasheet in which all patient identifiers have been removed.

The primary outcome will be the percentage of IPMN patients with at least one first-degree relative with pancreatic cancer or IPMN, or at least two first or second degree relatives with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes, including colorectal, gastric, breast, ovarian, and melanoma neoplasms. Secondary outcomes will be the relative risk of IPMN subtypes of higher malignant potential (main duct or mixed type location), more advanced histology (carcinoma in situ or invasive carcinoma), and recurrence following surgical resection amongst subjects with a family history.

详细描述

Intraductal papillary mucinous neoplasm (IPMN) is a cyst-like cancer of the pancreas that is increasingly being identified in medical practice, including during the screening of individuals at high risk of pancreatic cancer. It has been established that 10 to 20% of pancreatic cancers are familial. In comparison, there has been little research into the importance of genetic risk in IPMN incidence. The investigators will perform a retrospective chart review of patients with IPMN who were evaluated for surgical intervention at our tertiary referral center. The investigators are interested in determining the proportion of IPMN patients with a family history of pancreatic and other cancers. In addition, the investigators will assess if familial cancer risk is associated with increased risk for malignant IPMN and recurrence, relative to those patients without an inherited predisposition.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Tissue-confirmed diagnosis of intraductal papillary mucinous neoplasm or imaging suspicious for IPMN
  • Seen in consultation for IPMN at Columbia-Presbyterian Medical Center between 2002 and 2008

排除标准

  • Not meeting the inclusion criteria.

结局指标

主要结局

Percentage of IPMN patients with relatives with pancreatic cancer or IPMN

时间窗: 20 years

Extent of Family History: The primary outcome will be the percentage of IPMN patients with at least one first-degree relative with pancreatic cancer or IPMN, or at least two first or second degree relatives with pancreatic cancer, IPMN, or malignancies related to pancreatic cancer syndromes, including colorectal, gastric, breast, ovarian, and melanoma neoplasms.

次要结局

  • Percentage of IPMN patients exhibiting higher malignant potential or recurrence following surgical resection(20 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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