Development of a Novel Clinical Diagnostic Assay for Peripheral T-cell Lymphoma (PTCL)

开发外周 T 细胞淋巴瘤 (PTCL) 的新型临床诊断方法

基本信息

  • 批准号:
    9555564
  • 负责人:
  • 金额:
    $ 29.94万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2018
  • 资助国家:
    美国
  • 起止时间:
    2018-04-01 至 2020-03-31
  • 项目状态:
    已结题

项目摘要

Project Summary/Abstract Peripheral T-cell lymphoma (PTCL) is a heterogeneous cancer that constitutes up to 20% of all non-Hodgkin lymphoma (NHL). The World Health Organization classification recognizes a number of distinct subtypes of PTCL but the diagnosis of these different subtypes is challenging even for expert hematopathologists. Furthermore, 30-50% of PTCL cases are not classifiable into any specific subtype at all using current diagnostic methods. Patients with PTCL generally have a poor prognosis with current standard-of-care therapy, and no improvement in the outcome of PTCL patients has been achieved in the last two decades. However, novel therapies targeted to specific PTCL subtypes have recently begun testing, some with spectacular results. Accurate diagnosis of PTCL and its subtypes has therefore become essential to ensure selection of the most appropriate and effective treatment for each individual patient. This project will leverage seminal work performed by academic investigators associated with the Lymphoma/Leukemia Molecular Profiling Project (LLMPP), in which robust molecular gene expression (GE) signatures have been identified that are unique to each major subtype of PTCL. The project will build upon this work, utilizing it as the basis for the creation of a commercial assay for routine clinical application to improve the diagnosis, treatment, and outcomes of PTCL patients. HealthChart LLC, a recently founded molecular diagnostics firm focused on the development of novel diagnostic assays for niche indications in cancer and other diseases, has licensed the intellectual property and patent portfolio associated with the academic work and is the small business partner in these proposed studies. The overarching goal of this Phase 1 STTR proposal is to transition the “academic” PTCL diagnostic and prognostic GE signatures originally developed using fresh frozen specimens analyzed with expression microarrays to an optimized, locked-down signature applicable to formalin-fixed paraffin-embedded (FFPE) specimens analyzed on the NanoString nCounter platform. The two Aims of this proposal – Aim 1. Identify a reduced set of transcripts and create a novel model able to replicate the existing “academic” diagnostic and prognostic PTCL signature; Aim 2. Confirm the applicability of the refined diagnostic and prognostic PTCL gene signature sets on the nCounter platform (NanoString) for the analysis of FFPE specimens – will create an optimized and locked-down PTCL signature, establish performance specifications for inter-lab reproducibility, and validate the signature to a rigorous set of target metrics. These studies will enable application of the assay as a CLIA lab offering at the end of Phase 1, while positioning the PTCL assay for transition to Phase 2 development as an in vitro diagnostic (IVD) kit and possibly a companion diagnostic (CDx) for novel and/or existing PTCL therapies.
项目总结/文摘

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Wing C. Chan其他文献

Heterogeneity of large granular lymphocyte proliferations: delineation of two major subtypes.
大颗粒淋巴细胞增殖的异质性:两种主要亚型的划分。
  • DOI:
  • 发表时间:
    1986
  • 期刊:
  • 影响因子:
    20.3
  • 作者:
    Wing C. Chan;A. Mawle;Irene J. Check;Russell K. Brynes;Elliott F. Winton
  • 通讯作者:
    Elliott F. Winton
Mechanistic Elucidation of the Tumor-Promoting Role of Carcinoembryonic Antigen-Related Cell Adhesion Molecule 1 in B-Cell Receptor Signaling in Mantle Cell Lymphoma
  • DOI:
    10.1182/blood-2023-175064
  • 发表时间:
    2023-11-02
  • 期刊:
  • 影响因子:
  • 作者:
    Serene Xavier;Vivian Nguyen;Vishal Khairnar;An Phan;Lu Yang;Michael Nelson;Elizabeth Tseng;Aimin Li;Joo Y Song;Dennis D. Weisenburger;Wing C. Chan;Markus Müschen;Vu N. Ngo
  • 通讯作者:
    Vu N. Ngo
Lymphomas of follicles. Mantle cell and follicle center cell lymphomas.
滤泡淋巴瘤。
Large granular lymphocyte proliferation: an analysis of T-cell receptor gene arrangement and expression and the effect of in vitro culture with inducing agents.
大颗粒淋巴细胞增殖:T细胞受体基因排列和表达以及诱导剂体外培养效果的分析。
  • DOI:
  • 发表时间:
    1988
  • 期刊:
  • 影响因子:
    20.3
  • 作者:
    Wing C. Chan;Carol DahI;Thomas A. Waldmann;Susan Link;Alison Mawle;Janet K. A. Nicholson;Fritz H. Bach;K. Bongiovanni;Peter A. McCue;Elliott F. Winton
  • 通讯作者:
    Elliott F. Winton
Peripheral T cell lymphomas: from the bench to the clinic
外周 T 细胞淋巴瘤:从实验室到临床
  • DOI:
    10.1038/s41568-020-0247-0
  • 发表时间:
    2020-04-06
  • 期刊:
  • 影响因子:
    66.800
  • 作者:
    Danilo Fiore;Luca Vincenzo Cappelli;Alessandro Broccoli;Pier Luigi Zinzani;Wing C. Chan;Giorgio Inghirami
  • 通讯作者:
    Giorgio Inghirami

Wing C. Chan的其他文献

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{{ truncateString('Wing C. Chan', 18)}}的其他基金

Pre-analytical variables of bioanalytes affecting the accuracy of PTCL diagnostic and prognostic genetic signatures
生物分析物的分析前变量影响 PTCL 诊断和预后遗传特征的准确性
  • 批准号:
    10300391
  • 财政年份:
    2021
  • 资助金额:
    $ 29.94万
  • 项目类别:
Pre-analytical variables of bioanalytes affecting the accuracy of PTCL diagnostic and prognostic genetic signatures
生物分析物的分析前变量影响 PTCL 诊断和预后遗传特征的准确性
  • 批准号:
    10491082
  • 财政年份:
    2021
  • 资助金额:
    $ 29.94万
  • 项目类别:
Cooperative role of TET2 and IDH2 mutations in angioimmunoblastic T-cell lymphomagenesis
TET2 和 IDH2 突变在血管免疫母细胞 T 细胞淋巴瘤发生中的协同作用
  • 批准号:
    10672370
  • 财政年份:
    2021
  • 资助金额:
    $ 29.94万
  • 项目类别:
Pre-analytical variables of bioanalytes affecting the accuracy of PTCL diagnostic and prognostic genetic signatures
生物分析物的分析前变量影响 PTCL 诊断和预后遗传特征的准确性
  • 批准号:
    10684317
  • 财政年份:
    2021
  • 资助金额:
    $ 29.94万
  • 项目类别:
Cooperative role of TET2 and IDH2 mutations in angioimmunoblastic T-cell lymphomagenesis
TET2 和 IDH2 突变在血管免疫母细胞 T 细胞淋巴瘤发生中的协同作用
  • 批准号:
    10299140
  • 财政年份:
    2021
  • 资助金额:
    $ 29.94万
  • 项目类别:
Cooperative role of TET2 and IDH2 mutations in angioimmunoblastic T-cell lymphomagenesis
TET2 和 IDH2 突变在血管免疫母细胞 T 细胞淋巴瘤发生中的协同作用
  • 批准号:
    10453656
  • 财政年份:
    2021
  • 资助金额:
    $ 29.94万
  • 项目类别:
Molecular diagnostic and prognostic signatures for PTCL
PTCL 的分子诊断和预后特征
  • 批准号:
    10017897
  • 财政年份:
    2017
  • 资助金额:
    $ 29.94万
  • 项目类别:
Molecular diagnostic and prognostic signatures for PTCL
PTCL 的分子诊断和预后特征
  • 批准号:
    10226182
  • 财政年份:
    2017
  • 资助金额:
    $ 29.94万
  • 项目类别:
Molecular Signatures to Improve Diagnosis and Outcome Pr
改善诊断和结果的分子特征
  • 批准号:
    7913564
  • 财政年份:
    2009
  • 资助金额:
    $ 29.94万
  • 项目类别:
Gene expression profiling and pathway targeted therapy in peripheral T-cell
外周T细胞的基因表达谱和通路靶向治疗
  • 批准号:
    7715220
  • 财政年份:
    2009
  • 资助金额:
    $ 29.94万
  • 项目类别:

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