Biomarker Reference Lab
Biomarker Reference Lab
批准号:
10701257
负责人:
Leopoldo Nicolas Segal
金额:
$10.24万
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-05-04 至 2028-04-30
关键词:
AdjuvantBenignBiological AssayBiological MarkersBloodBlood specimenCancer PatientClinicalClinical Laboratory Improvement AmendmentsCollaborationsCost efficiencyCustomDNADNA ProbesDataDetectionDevelopmentDiagnosisDiagnosticDiseaseEarly Detection Research NetworkEarly identificationEvaluationExcisionFreezingGenesGenomeGoalsInfrastructureInterventionInvestigationLaboratoriesMalignant NeoplasmsMalignant neoplasm of lungMeasuresMetagenomicsNatureNeoadjuvant TherapyNon-Small-Cell Lung CarcinomaPatientsPlasmaProceduresPrognosisRNARecurrenceRecurrent Malignant NeoplasmReproducibilityRoleSamplingStandardizationSterilityStructure of parenchyma of lungTestingTissue SampleTissuesValidationWorkbiomarker developmentbiomarker validationcancer diagnosiscancer recurrencecohortdesigndiagnostic strategyexperiencegenomic signaturehigh riskmetabolomemetagenomemicrobialmicrobial genomicsmicrobial signaturemicrobiomenano-stringnext generation sequencingnovelnovel strategiespredictive signaturepreventprognosticrisk predictionsequencing platformtargeted sequencingtranscriptome
中文摘要
项目摘要(巴西雷亚尔)
纽约大学BCC EDRN的最终目标是制定临床实验室改进修正案(CLIA)
允许识别早期肺癌并预测复发风险的分级检测
早期疾病的术后切除。我们已经有很有希望的数据表明这是可以实现的
通过评估微生物和宿主基因组特征。这些将在生物标志物中进一步研究
发展实验室(BDL)与不可知组学方法,导致识别最佳性能
预测功能。生物标志物参考实验室(BRL)的目标是开发标准化的、
分析验证的生物标志物检测,将针对由
BDL。为了做到这一点,我们将有匹配的血浆,血沉棕黄层,和下呼吸道样本的使用
在BDL中作为参考样本用于BRL中我们定制样本组的“一级”临床验证。
在目标1中,我们将开发一种针对血液和组织的靶向微生物基因组下一代测序(NGS)面板。
下呼吸道样本可预测早期NSCLC的诊断和预后。将设计DNA探针
以BDL中鉴定的分类群为目标。在目标2中,我们将评估是否使用LC-100靶向代谢物组。
血液和下呼吸道标本中的MS方法可以预测早期NSCLC的诊断和预后。在
目标3,我们将测试一个定制的NanoString面板,用于从血沉棕黄层和下呼吸道最佳靶向的RNA
执行BDL中标识的特征。选定的队列将分为发现和验证。
成功的生物标志物将接受外部验证。拟议的工作将在我们的CLIA中进行
实验室基础设施。这里开发的管道将提供一种新颖的方法,
根据EDRN联盟中其他人确定的多个目标进行定制。虽然每一种方法都是不同的,
通过观察微生物DNA、代谢物或宿主RNA靶标特征,
一组确定的受试者将使我们能够估计结合不同类型的生物标志物测量的作用
同时通过不同的方法进行诊断和预后预测。这些调查可以
导致开发一种新的多方法生物标志物,将识别高风险受试者,
可能需要采取积极的干预措施。
英文摘要
Project summary (BRL)
The ultimate goal of the NYU BCC EDRN is to develop Clinical Laboratory Improvement Amendments (CLIA)
grade assays that will allow for identification of early stage lung cancer and will predict the risk of recurrence
post-surgical removal of early stage disease. We already have promising data that this can be accomplished
through evaluation of microbial and host genomic signatures. These will be further investigated in the Biomarker
Developmental Laboratory (BDL) with agnostic omics approaches leading to identification of best performing
predictive features. The goal of the Biomarker Reference Laboratory (BRL) is to develop standardized,
analytically validated-biomarker assays that will target promising microbial and host signatures identified by the
BDL. In order to do so, we will have matching plasmas, buffy coats, and lower airway samples to the ones used
in the BDL for discovery as reference samples for “first order” clinical validation of our custom panels in the BRL.
In Aim 1, we will develop a targeted microbial genomic next generation sequencing (NGS) panel for blood and
lower airway samples predictive of diagnosis and prognosis of early-stage NSCLC. DNA probes will be designed
targeting taxa identified in the BDL. In Aim 2, we will evaluate whether a targeted metabolite panel using an LC-
MS approach in blood and lower airway samples can predict diagnosis and prognosis of early-stage NSCLC. In
Aim 3, we will test a custom-made NanoString panel for RNA from buffy coats and lower airways targeting best
performing features identified in the BDL. The cohort selected will be divided in Discovery and Validation.
Successful biomarkers will then undergo external validation. The proposed work will be performed in our CLIA
approved laboratory infrastructure. The pipelines developed here will provide a novel approach that can be
customized to multiple targets identified by others in the EDRN consortium. While each approach is distinctly
looking at microbial DNA, metabolites or host RNA target signatures, the consistent use of samples from a
defined group of subjects will allow us to estimate the role of combining different types of biomarkers measured
in parallel through different approaches for diagnostic and prognostic prediction. These investigations can then
lead to the development of a new multi-approach biomarker that will identify high risk subjects where more
aggressive interventions might be warranted.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Administrative Core
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批准号:10701255
-
项目类别:
-
资助金额:$9.58万
-
财政年份:2023
-
负责人:Leopoldo Nicolas Segal
-
依托单位:
Biomarker Development Laboratory
-
批准号:10701256
-
项目类别:
-
资助金额:$50.52万
-
财政年份:2023
-
负责人:Leopoldo Nicolas Segal
-
依托单位:
BIOREPOSITORY OPTIMIZATION AND USE FOR ENDOTYPING CRITICALLY ILL SARS-COV-2 INFECTED PATIENTS
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批准号:10684890
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项目类别:
-
资助金额:$20.74万
-
财政年份:2022
-
负责人:Leopoldo Nicolas Segal
-
依托单位:
BIOREPOSITORY OPTIMIZATION AND USE FOR ENDOTYPING CRITICALLY ILL SARS-COV-2 INFECTED PATIENTS
-
批准号:10510084
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项目类别:
-
资助金额:$25.25万
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财政年份:2022
-
负责人:Leopoldo Nicolas Segal
-
依托单位:
Local microbiota signatures of pro-tumor immunity and checkpoint inhibition susceptibility in lung cancer
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批准号:10320008
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项目类别:
-
资助金额:$65.28万
-
财政年份:2020
-
负责人:Leopoldo Nicolas Segal
-
依托单位:
Local microbiota signatures of pro-tumor immunity and checkpoint inhibition susceptibility in lung cancer
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批准号:10202873
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项目类别:
-
资助金额:$16.95万
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财政年份:2020
-
负责人:Leopoldo Nicolas Segal
-
依托单位:
Local microbiota signatures of pro-tumor immunity and checkpoint inhibition susceptibility in lung cancer
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批准号:10545754
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项目类别:
-
资助金额:$62.66万
-
财政年份:2020
-
负责人:Leopoldo Nicolas Segal
-
依托单位:
Lung Microbiome and Inflammation in Early COPD
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批准号:8767264
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项目类别:
-
资助金额:$18.42万
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财政年份:2014
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负责人:Leopoldo Nicolas Segal
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依托单位:
海外基金