Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30,000
- 试验地点
- 13
- 主要终点
- Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes
研究概览
简要总结
This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured.
详细描述
PRIMARY OBJECTIVES:
I. To develop a cohort (biobank of biospecimens and data) of subjects without pancreatic cancer who are at highrisk for pancreatic cancer due to: a strong family history, a mutation in a known pancreatic cancer predisposition gene, or fukuoka worrisome or high-risk pancreatic cysts.
II. To follow the cohort subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes.
III. To make biospecimen available to PCDC-approved projects to validate potential biomarkers for performance using nested case-control prospective designs.
OUTLINE: This is an observational 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PDAC FAMILY HISTORY OR PDAC RELATED GENETIC MUTATIONS:
- •Age: 50 or older, plus at least one of the following:
- •Mutation unknown or absent:
- •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;
- •OR 2+ affected first degree relatives [(FDR), defined as blood related parents, siblings, or children]
- •Known pathogenic/likely pathogenic (P/LP) mutation in at least one of the following:
- •CDKN2A/p16, Peutz-Jeghers syndrome (PJS) serine/threonine kinase 11 (STK11), Hereditary pancreatitis with confirmed protease serine 1 (PRSS1)
- •OR 1+ or second degree relative (SDR) with PDAC and a known P/LP mutation in one or more of:
- •ATM, BRCA1, BRCA2, PALB2, Lynch syndrome (MLH1, MSH2, MSH6, PMS2, EPCAM), TP53
- •HIGH-RISK OR WORRISOME PANCREATIC CYSTS:
- •18 years of age or greater and meeting Fukuoka worrisome (FW) or Fukuoka high-risk (FHR) criteria
- •High risk stigmata:
- •Obstructive Jaundice in a patient with cystic lesion of the head of the pancreas
- •Enhancing mural nodule ≥ 5 mm
- •Main pancreatic duct ≥ 10 mm
- •Worrisome features:
- •Presence of pancreatic duct stricture, defined as focal pancreatic duct narrowing with upstream duct => 6 mm
- •Cyst ≥ 3 cm
- •Enhancing mural nodule < 5 mm
- •Thickened/Enhancing cyst wall
- •Main duct size 5-9 mm
- •Pancreatitis
- •Lymphadenopathy
- •Increased CA 19-9
- •Cyst growth rate ≥ 5 mm /2 years
排除标准
- •Is unable to provide informed consent
- •Has received a non-autologous bone marrow transplant or has an active hematologic malignancy (i.e., leukemia or lymphoma)
- •Current or prior history of PDAC or total pancreatectomy
- •Is currently a prison inmate
- •Is not able to speak or read English
研究组 & 干预措施
Observational
Participants undergo blood sample collection, complete questionnaires, have their medical records reviewed and undergo pancreatic cyst fluid collection during standard of care endoscopic ultrasounds fine needle aspiration.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes
时间窗: Up to study completion, as defined in description
Participants will be followed until study completion, defined as when one or more of the following occur: * Subject has provided a pre-treatment biospecimen after diagnosis with pancreatic ductal adenocarcinoma (PDAC) or it has been determined that collection of a pre-treatment biospecimen sample after PDAC diagnosis is infeasible. * Enrollment cyst determined to not be mucinous and thus not worthy of ongoing surveillance. * Subject has had a complete pancreatectomy. * Subject has died. * Study funding has ended
Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer
时间窗: Baseline (at enrollment)
Assessed by the number of specimens collected for subjects at right risk for pancreatic cancer due to a strong family history, a mutation in a known pancreatic cancer predisposition gene, or Fukuoka worrisome or high-risk pancreatic cysts.
次要结局
未报告次要终点