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:
- 金额:$ 93.64万
- 依托单位:
- 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:
- 关键词:Academic Medical CentersAfrican American populationAlternative SplicingBiological AssayBiological MarkersBiopsyCancer PatientCertificationClinicalClinical TreatmentCollaborationsCommunitiesDevelopmentDiagnosisDiagnostic testsDiseaseERG geneEarly Detection Research NetworkEarly DiagnosisFutureGene FusionGenerationsGoalsGuidelinesHealthIncidenceIndolentIndustryLaboratoriesMalignant NeoplasmsMalignant neoplasm of prostateMetastatic Prostate CancerMichiganMinority EnrollmentMinority GroupsMissionMutationNew YorkPSA screeningPathologyPatientsPerformancePopulationPopulation HeterogeneityPopulations at RiskProceduresProstateProstatic DiseasesRNA SplicingReproduction sporesResearchResearch DesignResearch PersonnelRunningSamplingScreening for Prostate CancerSpecificityStandardizationTMPRSS2 geneTestingTexasTherapeutic InterventionTimeTranscriptUnited StatesUniversitiesUntranslated RNAUrineValidationVariantVirginiaWorkbiomarker validationcancer biomarkerscircular RNAclinically significantcohortcommercializationcurative treatmentsdetection testearly detection biomarkershealth disparityimprovedindustry partnerinsertion/deletion mutationmedical schoolsmenmortalitymultidisciplinarynext generationnovelnovel diagnosticsnovel markerovertreatmentpersonalized risk predictionpreventshared decision makingspecific biomarkerstranscriptome sequencingtranscriptomicsurinary
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
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Point-Counterpoint: Clinical Pragmatism Should Prevail Over Biological Orthodoxy: "Pro" Perspective.
观点对立:临床实用主义应胜过生物学正统观念:“专业”观点。
- DOI:10.1097/ju.0000000000003512
- 发表时间:2023
- 期刊:
- 影响因子:0
- 作者:Penson,DavidF;Tosoian,JeffreyJ
- 通讯作者:Tosoian,JeffreyJ
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{{ truncateString('ARUL M CHINNAIYAN', 18)}}的其他基金
Michigan-VUMC Biomarker Characterization Center
密歇根-VUMC 生物标志物表征中心
- 批准号:
10483357 - 财政年份:2022
- 资助金额:
$ 93.64万 - 项目类别:
Exploring Precision Oncology: From Gene Fusions to lncRNAs
探索精准肿瘤学:从基因融合到 lncRNA
- 批准号:
10219190 - 财政年份:2018
- 资助金额:
$ 93.64万 - 项目类别:
Exploring Precision Oncology: From Gene Fusions to lncRNAs
探索精准肿瘤学:从基因融合到 lncRNA
- 批准号:
10462574 - 财政年份:2018
- 资助金额:
$ 93.64万 - 项目类别:
Exploring Precision Oncology: From Gene Fusions to lncRNAs
探索精准肿瘤学:从基因融合到 lncRNA
- 批准号:
10000857 - 财政年份:2018
- 资助金额:
$ 93.64万 - 项目类别:
Exploring Precision Oncology: From Gene Fusions to lncRNAs
探索精准肿瘤学:从基因融合到 lncRNA
- 批准号:
10680474 - 财政年份:2018
- 资助金额:
$ 93.64万 - 项目类别:
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