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Michigan-VUMC Biomarker Characterization Center

密歇根-VUMC 生物标志物表征中心

基本信息

批准号：
10684207
负责人：
ARUL M CHINNAIYAN
金额：
$ 93.64万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-15 至 2027-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10684207
关键词：
Academic Medical Centers African American population Alternative Splicing Biological Assay Biological Markers Biopsy Cancer Patient Certification Clinical Clinical Treatment Collaborations Communities Development Diagnosis Diagnostic tests Disease ERG gene Early Detection Research Network Early Diagnosis Future Gene Fusion Generations Goals Guidelines Health Incidence Indolent Industry Laboratories Malignant Neoplasms Malignant neoplasm of prostate Metastatic Prostate Cancer Michigan Minority Enrollment Minority Groups Mission Mutation New York PSA screening Pathology Patients Performance Population Population Heterogeneity Populations at Risk Procedures Prostate Prostatic Diseases RNA Splicing Reproduction spores Research Research Design Research Personnel Running Sampling Screening for Prostate Cancer Specificity Standardization TMPRSS2 gene Testing Texas Therapeutic Intervention Time Transcript United States Universities Untranslated RNA Urine Validation Variant Virginia Work biomarker validation cancer biomarkers circular RNA clinically significant cohort commercialization curative treatments detection test early detection biomarkers health disparity improved industry partner insertion/deletion mutation medical schools men mortality multidisciplinary next generation novel novel diagnostics novel marker overtreatment personalized risk prediction prevent shared decision making specific biomarkers transcriptome sequencing transcriptomics urinary

项目摘要

Project Summary/Abstract This application proposes the formation of the Michigan-Vanderbilt University Medical Center (VUMC) EDRN Biomarker Characterization Center (BCC). This BCC represents a collaborative, multi-disciplinary team of academic (University of Michigan (U-M) and VUMC) and industry (LynxDx) partners focused on discovering, developing, and scaling clinical-grade assays for the early detection of aggressive prostate cancer. Through previous EDRN efforts, our team characterized multiple important prostate cancer biomarkers, most notably the TMPRSS2-ETS gene fusions. Through collaboration with an EDRN Clinical Validation Center (CVC; Dr. Sanda PI), we developed, validated, and clinically implemented MyProstateScore (MPS), an early detection test incorporating urine quantification of two prostate cancer-specific transcripts—the TMPRSS2:ERG gene fusion and the long non-coding RNA (lncRNA) PCA3. Introduced in our CLIA laboratory, MPS informs shared decision making after PSA testing based on individualized risk predictions of aggressive prostate cancer on biopsy. Here, pairing the cancer-specific components of the MPS test with recent discovery of high-grade cancer-specific biomarkers, we outline the development, optimization, and clinical validation of the next generation of diagnostic tests – capable of reliably, selectively detecting potentially lethal cancers that stand to benefit from early curative treatment. Our Biomarker Developmental Laboratory (BDL) will employ the experimental platform, MPS-SEQ, for capture RNA-seq analysis of urine samples to detect aggressive prostate cancer transcripts, lncRNAs, circular RNAs, fusion transcripts, mutations, indels, and splice variants. Our Biomarker Reference Laboratory (BRL) will in parallel develop a clinical grade urine assay, MPS-50, for the multiplex QPCR analysis of up to 50 amplicons. While the first 50 amplicons of MPS-50 have already been nominated, future improvements of the assay content and platform will be informed by work carried out in our BDL. To fuel these studies, our BCC has identified urine biospecimen cohorts collected under rigorous standard operating procedures in compliance with PRoBE criteria including the Michigan Prostate SPORE, Emory University, the Center for Prostate Disease Research, University of Texas San Antonio Health, Eastern Virginia Medical School, and VUMC/Meharry Medical College. The overall Aims of this BCC serve to develop, assess, and optimize MPS-SEQ and MPS-50 for identifying high-grade prostate cancer in diverse at-risk populations. Our BRL will also focus on standardizing clinically-validated biomarker assays for consistent and reliable use in accordance with CLIA/CAP guidelines at the U-M Center for Translational Pathology in order to facilitate network consortium studies and at LynxDx in order to scale, commercialize, and obtain FDA approvals. As recognized by the EDRN, novel biomarkers specific for aggressive prostate cancer are urgently needed. Importantly, our mission and efforts extend beyond our BCC and prostate cancer, as we actively participate in the EDRN biomarker community and support continued collaborative efforts with other BCCs and CVCs to advance the overall EDRN mission.

项目总结/文摘