Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Detection rate of PC and precancerous lesion
研究概览
简要总结
100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years. This data will be used to determine the pancreatic cancer and precancerous lesion detection rate in High Risk Individuals (HRIs). Subjects may agree to annual imaging and annual biomarkers or to biomarkers only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a family history of PC as listed below or who have one of the following syndromes: Peutz-Jeghers syndrome - STK11; BRCA 1 and 2; PALB2; ATM; FAMMM / P16; HNPCC (Lynch) / MMR genes; Hereditary pancreatitis - PRSS1
- •Individuals with three or more affected blood relatives (1st, 2nd or 3rd degree)
- •Individuals with two or more affected blood relatives with PC, with at least one affected FDR, should be considered for screening.
- •Patients with a history of Peutz-Jeghers syndrome should be screened, regardless of family history of PC.
- •Patients with a known p16 (FAMMM syndrome) with one affected 1st or 2nd degree relative will be considered for screening.
- •Patients with a known BRCA1 or BRCA2 mutation with one affected 1st or 2nd degree relative should be considered for screening.
- •Patients with a known PALB2 mutation with one affected family member should be considered for screening.
- •Patients with a known Mismatch-repair gene-mutation carriers (Lynch syndrome) with one affected family member should be considered for screening.
排除标准
- •Not candidates for surgery
研究组 & 干预措施
Pathway 1
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 1
干预措施: Pancreatic Cancer Screening Pathway 1 (Other)
Pathway2
Individuals at high risk of pancreatic cancer who will participate in Pancreatic Cancer Screening Pathway 2
干预措施: Pancreatic Cancer Screening Pathway 2 (Other)
结局指标
主要结局
Detection rate of PC and precancerous lesion
时间窗: 5 years
次要结局
未报告次要终点