Pancreatic Cancer Early Detection Consortium
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 92
- 主要终点
- Development of PDAC
研究概览
简要总结
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up.
详细描述
The main objective of the PRECEDE Consortium is to build a shared resource to drive research in critical areas necessary for early detection and prevention of PDAC.
The PRECEDE Consortium is an observational prospective cohort study, with single or serial biosample collection (every 6-12 months) in defined high-risk groups.
A standardized procedure for collection and processing of human blood for the PRECEDE Consortium will be applied to all blood samples collected as part of the study. Barcoded samples will be stored at the clinical centers, using the specific labels for the PRECEDE study and corresponding data will be entered into the study database.
Clinical data and outcomes will be obtained from institutional databases or clinical records to correlate patient information with laboratory results from biospecimens obtained for research. Patients will be followed by their attending physician and receive the standard follow-up care after the procedure in which biospecimen was obtained. It is the intent that biospecimens will be made available to all consortium investigators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals from the following groups who present for clinical evaluation and assessment of PDAC risk at any of the participating sites can be offered participation in the PRECEDE database:
- •Individuals without history of PDAC meeting any of the following criteria:
- •2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.
- •2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
- •BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
- •Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
- •Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
- •Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+
- •Individuals without history of PDAC meeting any of the following criteria:
- •ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
- •2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
- •1 first degree relative with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member
- •Cohort 3 Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)
- •Cohort 4 Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.
- •Cohort 5 Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.
- •Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:
- •Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
- •Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
- •Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:
- •Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
- •Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
- •Diagnosed ≤ age 45
- •Cohort 6c Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b.
- •Cohort 6d Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c.
- •Cyst Cohort Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)
排除标准
- •Individuals not meeting the criteria above.
研究组 & 干预措施
Cyst Cohort
Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)
Cohort 2
Individuals without history of PDAC meeting any of the following criteria:
- ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
- 2+ relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in family
- 1 FDR with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in family member
Cohort 4
Individuals without history of PDAC presenting for evaluation who do not meet any criteria for 1-3, 6, or the Cyst Cohort.
Cohort 6a
Individuals diagnosed with PDAC or pancreatic high-grade dysplasia after enrollment in PRECEDE meeting any of the following criteria:
- Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
- Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
Cohort 6d
Individuals with PDAC seen at a PRECEDE site that do not meet the criteria for 6a, 6b, or 6c.
Cohort 3
Individual meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2)
Cohort 5
Individuals without history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site may be invited to participate in the PRECEDE database and to donate a biosample (e.g. blood, saliva, and/or buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4,6, and the Cyst Cohort.
Cohort 6b
Individuals with a personal history of PDAC or pancreatic high-grade dysplasia meeting any of the following criteria:
- Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other
- Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2,PMS2, PRSS1, STK11
- Diagnosed ≤ age 45
Cohort 6c
Individuals with newly diagnosed early stage (stage I or stage II) PDAC seen at a PRECEDE site that do not meet the criteria for 6a or 6b.
Cohort 1
Individuals without history of PDAC meeting any of the following criteria:
- 2+ relatives with PDAC on same side of family where 2 affected are first degree related to each other and at least 1 affected is first degree related to subject; age 50+ or ≤10 years younger than earliest PDAC in family at time of diagnosis.
- 2 affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
- BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
- Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
- Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
- Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+
结局指标
主要结局
Development of PDAC
时间窗: Through study completion, an average of 6 years
Diagnosis of PDAC
次要结局
未报告次要终点