Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Biospecimen Acquisition
研究概览
简要总结
Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts.
详细描述
Subjects with Fukuoka Worrisome (FW) or Fukuoka High Risk (FHR) pancreatic cysts will be enrolled and assigned to Immediate Surgery or Clinical Follow-up groups based on clinical management as determined by the treating physicians. Blood, stool, pancreas cyst fluid, and pancreas juice specimens will be collected from participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris
- •Patients with suspected cystic neoplasm of the pancreas
- •Able to provide written informed consent
排除标准
- •Pregnant and/or nursing
- •Incarceration
- •Imaging showing possible pancreatic cancer
- •Prior history of pancreatic cancer or pancreatic surgery
- •History of receiving systemic chemotherapy or abdominal radiation within the last 5 years
- •Previous therapy for a pancreatic cystic lesion
- •History of pancreatic necrosis
- •Diagnosis of cancer (other than non-melanoma skin cancer) within the last 5 years
研究组 & 干预措施
Clinical Follow-up
Participants not undergoing surgery will be assigned to the "Clinical Follow-up" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. All participants in the Clinical Follow-up group will be contacted yearly for a telephone interview until they undergo surgery, die, receive a diagnosis that excludes them from the study, or for 5 years, and interval medical records will be obtained and reviewed. During follow-up results of clinically indicated follow-up imaging studies will be abstracted
干预措施: Blood, stool, pancreatic juice and cyst fluid collection (Diagnostic Test)
Clinical Follow-up
Participants not undergoing surgery will be assigned to the "Clinical Follow-up" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. All participants in the Clinical Follow-up group will be contacted yearly for a telephone interview until they undergo surgery, die, receive a diagnosis that excludes them from the study, or for 5 years, and interval medical records will be obtained and reviewed. During follow-up results of clinically indicated follow-up imaging studies will be abstracted
干预措施: Endoscopy Exam (Procedure)
Surgical
Participants scheduled for surgical resection after their initial clinical evaluation will be assigned to the "Immediate Surgery" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. Participants in the Immediate Surgery group will be followed until the surgical pathology of their pancreatic cyst is known.
干预措施: Blood, stool, pancreatic juice and cyst fluid collection (Diagnostic Test)
Surgical
Participants scheduled for surgical resection after their initial clinical evaluation will be assigned to the "Immediate Surgery" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. Participants in the Immediate Surgery group will be followed until the surgical pathology of their pancreatic cyst is known.
干预措施: Pancreatic Surgery (Procedure)
结局指标
主要结局
Biospecimen Acquisition
时间窗: 5 years
Number of biospecimens collected
High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group
时间窗: 5 years
To validate the diagnostic accuracy of cyst fluid methylated DNA marker (MDM) assays for detection of HGD and cancer in pancreatic cysts undergoing surgical resection
次要结局
- High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group(5 years)