A Pancreatic Cancer Screening Study in Hereditary High Risk Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Early Stage Pancreatic Cancer or Precursor Lesions
研究概览
简要总结
The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.
详细描述
Individuals 50 years of age and older who have a family history of pancreatic cancer will be recruited through the offices of primary care physicians and endocrinologists. Those meeting initial criteria will meet with a research APRN and will undergo a secondary screen to determine eligibility. Individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. MRI will be performed annually for 3 years (4 in total). Any abnormalities on MRI will be reviewed by a multi-disciplinary tumor board and discussed with the participant. The costs of MRI will be covered by the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a BRCA1, BRCA2, LYNCH SYNDROME, ATM, PALB2, CDKN2A, or related gene mutation (one of the following is required for questions 1-3)
- •For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.
- •For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.
- •The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2, ATM, PALB2, CDKN2A, or similar high-risk gene mutation and has at least 1 first- or second-degree relative with PC.
- •The individual is at least 50 years old or 10 years younger than the youngest relative with PC.
- •ECOG Performance Status of 0-
- •No known contraindications to MRI examination or gadolinium contrast.
- •Willing to undergo MRI and screening for metal implants or metal injury.
- •Estimated GFR >29 mL/min
- •Ability to provide informed consent.
- •Willing to return to study site for all study assessments.
- •Registration-
排除标准
- •Prior history of pancreatic cancer.
- •Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
- •Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
- •Hereditary pancreatitis.
- •eGFR < 30 mL/min
- •Contraindication to MRI examination or gadolinium contrast.
- •Pregnant or nursing women.
- •Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.
研究组 & 干预措施
FAMILIAL PANCREATIC CANCER and/or GENE MUTATION
An inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer.
干预措施: MRI/MRCP (Diagnostic Test)
结局指标
主要结局
Early Stage Pancreatic Cancer or Precursor Lesions
时间窗: Through study completion, up to 3 years
Incidence of Pancreatic Cancer or precursor lesions within a population of individuals with a strong family history of pancreatic cancer or known genetic mutation compared to the expected incidence in the general population.
次要结局
- Serial Pancreatic MRI Screening(Through study completion, up to 3 years)
- Serum Bio-bank(Through study completion, up to 3 years)
研究者
Richard Frank
Director, Cancer Research
Nuvance Health