Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 4
- 主要终点
- Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms
研究概览
简要总结
The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.
详细描述
In this research study, investigators will combine blood-based tests and review of symptoms with standard-of-care pancreatic cancer screening procedures to see if pancreatic cancer can be detected early among individuals with increased risk. Pancreatic cancer screening procedures include Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI), or Magnetic Resonance Cholangiopancreatography (MRCP).
The research study procedures include screening for eligibility, questionnaires, clinic visits, endoscopic ultrasound (EUS) or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples.
Participation in this research study will be a minimum of 30 months and up to 20 years via review of medical records and the annual collection of blood and stool samples.
It is expected that about 5,000 people will take part in this research study.
This study is supported by the Hale Family Research Center at Dana-Farber Cancer Institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must meet any of the following:
- •Individuals with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years.
- •Individuals with pathogenic/likely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).
- •Individuals with pathogenic/likely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND
- •Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic/likely pathogenic germline variant.
- •Individuals with pathogenic/likely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).
- •Individuals with familial pancreatic cancer including:
- •Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant, OR
- •Family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic/likely pathogenic germline variant, OR
- •Family history of exocrine pancreatic cancer in ≥3 first- and/or second-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant.
- •Individuals who are undergoing clinically recommended pancreatic cancer surveillance.
排除标准
- •Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.
- •Individuals with any active metastatic cancer.
- •Individuals who are unable to give informed consent.
- •Individuals who are under the age of 18 (infants, children, teenagers).
- •Individuals unable to tolerate Magnetic Resonance Imaging/Magnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound.
- •Pregnant women are unlikely to be undergoing screening procedures and will not be considered eligible but can consent to the study at a later date.
研究组 & 干预措施
Pancreatic Cancer High-Risk Participants
Study procedures will be conducted as follows:
- Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP).
- Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months.
- Blood tests and questionnaires every 6 months.
- Follow up visits.
干预措施: Screening Blood Tests (Other)
Pancreatic Cancer High-Risk Participants
Study procedures will be conducted as follows:
- Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP).
- Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months.
- Blood tests and questionnaires every 6 months.
- Follow up visits.
干预措施: Endoscopic Ultrasound (Diagnostic Test)
Pancreatic Cancer High-Risk Participants
Study procedures will be conducted as follows:
- Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP).
- Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months.
- Blood tests and questionnaires every 6 months.
- Follow up visits.
干预措施: Magnetic Resonance Imaging (Combination Product)
Pancreatic Cancer High-Risk Participants
Study procedures will be conducted as follows:
- Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP).
- Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months.
- Blood tests and questionnaires every 6 months.
- Follow up visits.
干预措施: Magnetic Resonance Cholangiopancreatography (Combination Product)
结局指标
主要结局
Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms
时间窗: 6-monthly for 3 years with 5-year follow-up
Subjects will be considered imaging-negative and assay-positive if: 1) the subject has a study visit that yields any newly positive CA19-9 (\>35U/mL or \>=20% increase) or diabetes (FBG \>100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score \>=3 with negative MRI and/or EUS at that visit or within six months prior to that visit; and 2) has a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia within two years after that visit.
Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms
时间窗: 6-monthly for 3 years with 5-year follow-up
Subjects will be counted in this metric if they have pathological tissue confirmation of a pancreatic cancer or high-grade dysplasia during each observation period.
Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms
时间窗: 6-monthly for 3 years with 5-year follow-up
Subjects will be considered imaging-positive if they have a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia that was initially detected on standard-of-care screening MRI or EUS during each observation period.
次要结局
- Incremental Yield of Blood-Based Assays over Standard-of-Care Screening(6-monthly for 3 years)
- Clinical Predictors of Neoplastic Development(up to 8 years)
- Negative Predictive Value of Blood Assays(6-monthly for 3 years)
- Proportion of Screen-Detected, Resected Pancreatic Lesions(6-monthly for 3 years)
- Proportion of Non-Worrisome Pancreatic Lesions(6-monthly for 3 years)
- Positive Predictive Value of Blood Assays(6-monthly for 3 years)
- Number of False-Positive Assay Results(6-monthly for 3 years)
- Number of Non-PDAC Cancer Diagnoses(6-monthly for 3 years)
研究者
Matthew B. Yurgelun, MD
Principal Investigator
Dana-Farber Cancer Institute