Management and Data Coordination Unit for PCDC

PCDC 管理和数据协调单元

• 批准号: 10524827
• 负责人: Ann Laura Oberg
• 金额: $ 65.98万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10524827
• 关键词: Adherence; Administrative Coordination; Biological Markers; Biological Specimen database; Biometry; Blinded; Cancer Detection; Clinic; Communication; Communities; Consultations; Data; Data Analyses; Data Collection; Data Coordinating Center; Databases; Development; Diagnosis; Disease; Documentation; Early Diagnosis; Early Intervention; Educational workshop; Enrollment; Ensure; Evaluation Studies; Experimental Designs; Future; Goals; Grant; Human Resources; Infrastructure; Institution; Institutional Review Boards; Knowledge; Lead; Leadership; Lesion; Logistics; Malignant Neoplasms; Malignant neoplasm of pancreas; Monitor; Pancreatic Ductal Adenocarcinoma; Participant; Patient Recruitments; Patients; Phase; Policies; Population; Procedures; Process; Protocols documentation; Randomized; Reproducibility; Research; Research Design; Research Personnel; Resources; Role; Sampling; Secure; Site; Statistical Data Interpretation; Strategic Planning; Testing; Time; Triage; United States National Institutes of Health; Update; Validation; Work; biobank; biomarker discovery; biomarker validation; case control; clinically relevant; cohort; data handling; data management; early detection biomarkers; experience; high risk; imaging biomarker; improved; innovation; meetings; molecular marker; multidisciplinary; programs; prospective; protocol development; repository; research study; sample collection; screening; symposium; tool; virtual

PROJECT SUMMARY Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal cancer, partially owing to lack of effective biomarkers and/or screening strategies. The 5-year survival of patients with localized PDAC is 39% compared to 3% in patients diagnosed with metastatic disease, which indicates that detecting PDAC at early stage positively impacts survival. A centrally curated/managed multi-institution biospecimen resource containing prospectively collected, well-annotated biospecimens representing clinically relevant, diverse PDAC screening populations is desperately needed. The overall goal of the Pancreatic Cancer Detection Consortium (PCDC) Management and Data Coordinating Center (MDCU) is to facilitate the PCDC’s role in developing and utilizing high quality, well annotated samples for PDAC biomarker discovery, triage, pre-validation, and validation. The PCDC consortium is composed of multiple U01 Research Units (RU) and the MDCU, with NCI cooperation and central biospecimen storage at the NCI Frederick Central Repository. We will leverage our expertise and knowledge gained during the previous grant cycle to reinforce existing and new PCDC initiatives through expanded coordination, and strengthening the infrastructure to support management of the PCDC Reference Sets and Signature Protocols. Our Specific Aims are 1) To provide outstanding and timely administrative coordination and logistical support for the Pancreatic Cancer Detection Consortium. 2) To strategically plan, coordinate and implement the development of a well-annotated, uniformly collected and managed central PCDC biorepository and database. 3) To provide the highest quality biostatistical leadership of PCDC collaborative experimental design, study conduct, and analysis, and to provide biostatistical consultation to PCDC RUs. The strengths of the MDCU are the breadth and depth of knowledge and understanding of PDAC provided by MDCU personnel who will innovatively apply time tested infrastructure tools and strategies to consortium management, and our vast experience in enhancing the scientific needs of PCDC collaborative research. Our multidisciplinary team is committed to continue its leadership and contribution to the PCDC organization to advance the early detection of pancreatic cancer.

项目总结 摘要胰腺导管腺癌是一种高度致命性的癌症，部分原因是缺乏有效的治疗方法。 生物标志物和/或筛选策略。相比之下，局限型PDAC患者的5年生存率为39% 在诊断为转移性疾病的患者中为3%，这表明在早期检测PDAC 对生存有积极的影响。集中管理/管理的多机构生物样品资源，包括 前瞻性收集、注解良好的生物标本，代表临床相关的、多样化的PDAC筛查 人口是迫切需要的。胰腺癌检测联盟(PCDC)的总体目标 管理和数据协调中心(MDCU)是为了促进PCDC在开发和利用方面的作用 用于PDAC生物标记物发现、分类、预验证和验证的高质量、注释良好的样本。这个 PCDC联盟由多个U01研究单位(RU)和MDCU组成，与NCI合作和 NCI Frederick中央储存库的中央生物样品存储。我们将利用我们的专业知识和 在上一个赠款周期中获得的知识，以加强现有的和新的PCDC倡议，方法是 扩大协调，加强基础设施，以支持PCDC参考资料的管理 SET和签名协议。我们的具体目标是：1)提供卓越和及时的行政管理 为胰腺癌检测联盟提供协调和后勤支持。2)战略谋划， 协调和实施一个注解良好、统一收集和管理的中央PCDC的发展 生物库和数据库。3)为PCDC提供最高质量的生物统计领导 实验设计、研究实施和分析，并为PCDC RU提供生物统计咨询。这个 MDCU的优势在于对PDAC的知识和理解的广度和深度 创新地将经过时间考验的基础设施工具和战略应用于联合体管理的人员， 以及我们在增强PCDC合作研究的科学需求方面的丰富经验。我们的多学科 团队致力于继续领导和贡献PCDC组织，以推动早期 胰腺癌的检测。