Core B - Biospecimen/Pathology Core

核心 B - 生物样本/病理学核心

基本信息

批准号：
10652337
负责人：
Iman Osman
金额：
$ 25.1万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-19 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10652337
关键词：
Aliquot Biological Specimen Banks Biological Specimen database Blood Blood specimen Caring Cell Separation Clinical Clinical Data Clinical Trials Collaborations Collection Communities Data Databases Development Ensure Feces Goals Health Human Human Resources Industry Informed Consent Institution International Link Lymphocyte Metastatic Melanoma Mission Molecular Nucleic Acids Pathologic Pathology Patient Rights Patients Peripheral Blood Mononuclear Cell Phase III Clinical Trials Plasma Positioning Attribute Preparation Process Prognostic Marker Program Research Project Grants Protocols documentation Quality Control Research Research Infrastructure Research Personnel Research Project Grants Resectable Resected Resources Scientist Serum Services Site Skin Cancer Structure T-Lymphocyte Tissue Sample Tissues Translational Research Unresectable Whole Blood Work biobank career clinical development design follow-up improved industry partner innovation melanoma novel participant enrollment patient oriented patient privacy personalized management phase III trial predictive marker programs prospective repository infrastructure stool sample tool translational research program

项目摘要

PROJECT SUMMARY The goal of the NYU Melanoma SPORE Core B (Biospecimen Procurement & Utilization Core) is to stimulate patient-centered melanoma translational research by providing all NYU Melanoma SPORE investigators— including research project co-leaders, Career Enhancement Program (CEP) awardees, and Developmental Research Program (DRP) awardees—with both: 1) access to high-quality melanoma biospecimens linked to prospectively collected clinical and pathological data, and 2) innovative services that promote the aims of those projects. Core B will maintain and expand the clinicopathological data and corresponding biospecimen (tissue, blood, and stool) resources of the NYU Melanoma Clinicopathological-Biospecimen Database and Repository for the SPORE’s study of resected and unresectable metastatic melanoma patients. To execute the central scientific strategy of the NYU Melanoma SPORE, Core B will coordinate with industry partners to ensure the acquisition, processing, and distribution of nearly 10,000 human biospecimens from melanoma patients enrolled in multi-site phase III clinical trials. Core B will process biospecimens, including performing nucleic acid extraction and T-cell isolation, and provide specialized, innovative pathology services to support the aims of full SPORE research projects, CEP projects, and DRP projects. Through a governance committee, Core B will also provide oversight of SPORE biospecimen use. Building on the NYU Melanoma Clinicopathological-Biospecimen Database and Repository’s infrastructure, biospecimen resources, and extensive support of NYU Melanoma Program studies internally and with other institutions, Core B will stimulate collaborations within the NYU Melanoma SPORE community as well as with outside collaborators, including other currently active Melanoma and Skin Cancer SPOREs. Given the considerable translational research infrastructure and resources at NYU, Core B personnel will also work closely with the Administrative Core to ensure the most efficient use of institutional resources without replication of efforts. Overall, Core B will provide high quality, annotated melanoma patient biospecimens to all SPORE studies to support the NYU Melanoma SPORE’s mission to develop clinically impactful prognostic and predictive biomarkers for the personalized management of resectable melanoma patients.

项目概要纽约大学黑色素瘤 SPORE 核心 B（生物样本采购和利用核心）的目标是刺激以患者为中心的黑色素瘤转化研究，为所有纽约大学黑色素瘤 SPORE 研究人员提供—— 包括研究项目联合负责人、职业提升计划 (CEP) 获奖者和发展研究计划 (DRP) 获奖者——同时获得：1) 获得与以下相关的高质量黑色素瘤生物样本前瞻性收集的临床和病理数据，以及 2) 促进这些目标的创新服务核心 B 将维护和扩展临床病理数据和相应的生物样本（组织、血液和粪便）纽约大学黑色素瘤临床病理学生物样本数据库和存储库资源用于 SPORE 对已切除和不可切除的转移性黑色素瘤患者的研究。纽约大学黑色素瘤 SPORE 的科学战略，核心 B 将与行业合作伙伴协调，以确保采集、处理和分发来自登记的黑色素瘤患者的近 10,000 份人类生物样本在多中心 III 期临床试验中，Core B 将处理生物样本，包括进行核酸提取。和 T 细胞分离，并提供专业、创新的病理学服务，以支持完整 SPORE 的目标 Core B 还将通过治理委员会提供研究项目、CEP 项目和 DRP 项目。以纽约大学黑色素瘤临床病理学生物样本为基础对 SPORE 生物样本的使用进行监督。数据库和存储库的基础设施、生物样本资源以及纽约大学黑色素瘤的广泛支持项目内部研究以及与其他机构的合作，核心 B 将促进纽约大学内部的合作黑色素瘤 SPORE 社区以及外部合作者，包括其他当前活跃的黑色素瘤和皮肤癌孢子。鉴于纽约大学拥有大量的转化研究基础设施和资源，核心 B 人员也将与行政核心密切合作，确保最有效地利用机构资源，而无需复制努力。总体而言，Core B 将为所有 SPORE 研究提供高质量、带注释的黑色素瘤患者生物样本支持纽约大学黑色素瘤 SPORE 的使命，即开发具有临床影响力的预后和预测用于可切除黑色素瘤患者个性化管理的生物标志物。