Core 1: Stanford Breast Metastasis Center Biospecimen and Pathology Core

核心 1：斯坦福乳腺转移中心生物样本和病理学核心

• 批准号: 10272392
• 负责人: GREGORY BEAN
• 金额: $ 26.33万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-14 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10272392
• 关键词: Address; Archives; Bar Codes; Biological Assay; Biopsy; Blood specimen; Breast; Breast Cancer Patient; Breast Oncology; Breast cancer metastasis; Cancer Relapse; Cell Survival; Cellularity; Clinical; Clinical Data; Clinical Trials; Consent; Correlative Study; Cryopreservation; Data; Databases; Diagnosis; Disease; Disease Progression; Distant Metastasis; ERBB2 gene; Early treatment; Emergency Department patient; Estrogen receptor positive; Evolution; Formalin; Generations; Genomics; Goals; Immune; Immunohistochemistry; Institutional Review Boards; Laboratories; Link; Location; Longitudinal cohort; Longterm Follow-up; Mammary Gland Parenchyma; Mammary Neoplasms; Management Information Systems; Medical Oncologist; Metadata; Metastatic breast cancer; Modernization; Molecular; Nature; Neoadjuvant Therapy; Neoplasm Metastasis; Oncology; Organoids; Outcome; Pathologic; Pathologist; Pathology; Patient Recruitments; Patients; Pattern; Phase II Clinical Trials; Phase Ib Trial; Principal Investigator; Procedures; Process; Proteomics; Protocols documentation; Quality Control; Recurrence; Relapse; Research; Research Personnel; Resolution; Sampling; Scanning; Secure; Site; Slide; Source; Specimen; Standardization; Subgroup; Surgeon; Survival Rate; Tissue Banks; Tissue Microarray; Tissues; Translational Research; Tumor Markers; Tumor Tissue; Tumor-Infiltrating Lymphocytes; bean; biobank; biomarker-driven; breast cancer survival; clinically relevant; cohort; design; electronic data; experience; follow-up; high risk; improved; insight; malignant breast neoplasm; metastatic process; multidisciplinary; multiple omics; new therapeutic target; novel therapeutic intervention; preservation; prospective; recruit; relapse risk; routine care; sample collection; sample fixation; spatiotemporal; therapy resistant; transcriptomics; triple-negative invasive breast carcinoma; tumor

Project Summary/Abstract In order to investigate the processes of breast cancer metastatic relapse, longitudinal cohorts of breast tumor tissue with detailed clinical information are needed. Thus, an integral function of the Stanford Breast Metastasis Center (SBMC) will be the acquisiton, processing, clinical annotation, and curation of hundreds of breast tumors collected across multiple sites and stages of disease progression. To this end, this project describes the aims and functions of the SBMC Biospecimen and Pathology Core. The Core will be led by experienced breast pathologist Dr Gregory Bean, who will implement and iteratively improve standard operating procedure protocols for processing, pathologic review, and generation of tissue microarrays for the Core samples. The lab of principal investigator Dr Christina Curtis will assist in sample collection and processing to enable numerous downstream multi-omic protocols, in which they have extensive expertise, as well as breast organoid generation. Breast medical oncologist Dr Jennifer Caswell-Jin and breast surgeon Dr Irene Wapnir will recruit participants to prospective tissue acquisition protocols and will design and review clinical annotation procedures. The Core will draw samples from six established efforts, including two completed clinical trials (TRIO B07 and TONIC), two prospectively recruiting clinical trials (NCT04504331 and TERPSICHORE), an existing Institutional Review Board (IRB)-approved protocol whereby archival tumor specimens are collected retrospectively, and an existing IRB-approved protocol whereby prospective serial tumor and blood samples are collected from consented patients with breast cancer undergoing routine care. In Aim 1, longitudinal tumor samples throughout treatment and metastasis will be collected from these sources. Prospectively collected samples will be subjected to rapid processing to include formalin fixation, cryopreservation, and preservation of viable cells for organoids; H&E slides will be scanned and reviewed for tumor cellularity and tumor-infiltrating lymphocytes; standardized immunohistochemistry will be performed; and detailed information about location and orientation will be recorded. In Aim 2, a highly integrated database will be constructed to provide linkage of these collected biospecimens with high quality demographic, clinical, pathologic, and treatment data. This secure Research and Electronic Data Capture database will include detailed clinical information and will link biospecimens via barcodes to the Laboratory Information Management System, where information on all downstream assays performed on samples is stored. In Aim 3, a framework for sharing high quality, de-identified biospecimens and clinical data within the SBMC will be established. Summaries of de-identified clinical metadata that can be shared with investigators across the SBMC will be generated, and rapid identification of project-specific cohorts enabled. Successful completion of these Aims will result in an annotated, longitudinal breast cancer biospecimen cohort with unprecedented molecular and clinical annotation and the potential to reveal new insight into the metastatic niche and breast cancer evolution.

项目摘要/摘要 为了研究乳腺癌转移性复发的过程，乳腺肿瘤的纵向人群 需要详细的临床信息的组织。因此，斯坦福乳房转移的积分功能不可或缺 中心（SBMC）将是数百种乳腺肿瘤的侵犯，加工，临床注释和策展 在多个地点和疾病进展的阶段收集。为此，该项目描述了目标 SBMC生物测量和病理核心的功能。核心将由经验丰富的乳房领导 病理学家Gregory Bean博士将实施并迭代改善标准操作程序协议 用于处理，病理审查和核心样品的组织微阵列。校长实验室 调查员克里斯蒂娜·柯蒂斯（Christina Curtis）博士将协助采样收集和处理，以使许多下游能够 具有广泛专业知识的多摩尼克方案以及乳房器官的产生。胸部 医学肿瘤学家Jennifer Caswell-Jin博士和乳房外科医生Irene Wapnir博士将招募参与者 前瞻性组织采集方案，并将设计和审查临床注释程序。核心意愿 从六项既定努力中绘制样品，包括两项完成的临床试验（三重奏B07和补品），两个 前瞻性招募临床试验（NCT04504331和Terpsichore），现有的机构审查 董事会（IRB）批准的协议，回顾性地收集了档案肿瘤标本 IRB批准的方案，从同意中收集前瞻性串行肿瘤和血液样本 经过常规护理的乳腺癌患者。在AIM 1中，整个治疗过程中的纵向肿瘤样品 并将从这些来源收集转移。前瞻性收集的样品将受到快速的影响 处理以包括福尔马林固定，冷冻保存以及为器官的可行细胞保存；他 载玻片将被扫描和审查，以了解肿瘤细胞性和肿瘤浸润淋巴细胞；标准化 将进行免疫组织化学；以及有关位置和方向的详细信息 记录。在AIM 2中，将构建一个高度集成的数据库，以提供这些收集的链接 具有高质量人口，临床，病理和治疗数据的生物测量。这项安全的研究和 电子数据捕获数据库将包括详细的临床信息，并将通过 实验室信息管理系统的条形码，所有下游测定的信息 在样品上执行的存储。在AIM 3中，一个共享高质量，去识别的生物测量和的框架 将建立SBMC中的临床数据。可以共享的去识别临床元数据的摘要 将生成整个SBMC的研究人员，并快速识别对项目特定人群的启用。 这些目标的成功完成将导致带注释的纵向乳腺癌生物镜同学 具有前所未有的分子和临床注释，并有可能揭示转移性的新见解 利基和乳腺癌的演变。