Development of a urine test for the early detection of liver cancer

开发用于早期发现肝癌的尿液检测

基本信息

批准号：
10006054
负责人：
Selena Lin
金额：
$ 100万
依托单位：
JBS SCIENCE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-07-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10006054
关键词：
AFP gene Automation Award Biological Assay Biological Markers Blinded Blood Circulation Businesses Cancer Etiology Categories Certification Cessation of life Clinical Collaborations Collection Current Procedural Terminology Codes DNA Markers Data Development Disease Drops Early Diagnosis Edetic Acid Epigenetic Process Evaluation Funding Genetic Goals Guidelines Hepatology Hour Journals Laboratories Malignant Neoplasms Malignant neoplasm of liver Manuscripts Measures Medical Methods Modification Non-Invasive Cancer Detection Organ Patients Performance Phase Populations at Risk Primary Malignant Neoplasm of Liver Procedures Professional Organizations Protocols documentation Publishing Recurrence Risk Science Screening for Hepatocellular Cancer Serum Standardization Survival Rate Temperature Testing Transportation Urine Validation alpha-Fetoproteins base cell free DNA clinical research site commercialization effective therapy improved liquid biopsy outcome forecast performance tests phase 2 study precision medicine public health relevance screening standard of care success tumor DNA validation studies

项目摘要

Development of a urine test for the early detection of liver cancer The need to develop an effective method for detecting liver cancer is urgent. HCC, a primary liver cancer, is the third leading cause of cancer deaths worldwide and the fastest rising cancer in US. HCC has a 5-year survival rate of less than 15%, if detected early, the survival rate can be as high as 40%. The survival rate drops significantly, however, to as low as 2% if the cancer has spread to other organs. We have successfully accomplished the proposed milestones from our Phase II award (5R44CA165312-04) to develop an HCC screening test (the JBS HCC test) that can identify 30% more HCC than serum AFP, the current most used biomarker for HCC screening. This phase IIB application is to bridge the gap between our successful accomplishments in the Phase II period and commercialization of the JBS HCC test for HCC screening, so more people with HCC can benefit from early detection. The early detection of HCC is critical for the effective treatment and cure of this disease. Although the JBS test shows great promise to improve liver cancer screening, there are steps (identified as milestones in this application) that need to be taken before the test can reach at-risk patients for HCC. These steps include CLIA certification (Aim 1) so that the test can be marketed as a laboratory developed test (LDT), and filing request for a CPT code for the third party payee reimbursement, and evaluation of performance through a multicenter, blinded validation study to generate data supporting clinical benefit so the test can be considered as a standard of care for HCC screening in at-risk populations (Aim 2), and standardization of urine collection, storage, and transportation, and automation of urine cfDNA isolation to facilitate commercialization (Aim 3). Thus, three specific Aims are proposed to prepare for the launch of the JBS HCC screening test to the market.

开发用于早期发现肝癌的尿液检测迫切需要开发一种有效的肝癌检测方法。 HCC，原发性肝脏癌症是全球第三大癌症死亡原因，也是美国增长最快的癌症。 HCC的5年生存率低于15%，如果及早发现，生存率可高达为 40%。然而，如果癌症已扩散至其他器官。我们已经成功实现了第二阶段的拟议里程碑奖 (5R44CA165312-04) 开发 HCC 筛查测试（JBS HCC 测试），该测试可以识别比血清 AFP（目前 HCC 筛查最常用的生物标志物）多 30% 的 HCC。这一阶段 IIB的申请是为了弥补我们与第二阶段的成功成果之间的差距用于 HCC 筛查的 JBS HCC 检测商业化，让更多 HCC 患者能够受益于早期发现。肝癌的早期发现对于有效治疗和治疗至关重要治愈此病。尽管 JBS 测试显示出改善肝癌筛查的巨大希望，在测试之前需要采取一些步骤（在此应用程序中被标识为里程碑）可以接触到肝癌高危患者。这些步骤包括 CLIA 认证（目标 1），以便测试可以作为实验室开发的测试 (LDT) 进行销售，并提交 CPT 代码请求第三方收款人报销，并通过多中心、盲法进行绩效评估验证研究生成支持临床益处的数据，因此该测试可以被视为高危人群 HCC 筛查的护理标准（目标 2）以及尿液标准化尿液 cfDNA 分离的收集、储存和运输以及自动化，以促进商业化（目标 3）。因此，提出了三个具体目标，为启动 JBS HCC 筛查测试推向市场。

项目成果

期刊论文数量（18）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Characterization of the hepatitis B virus DNA detected in urine of chronic hepatitis B patients.

慢性乙型肝炎患者尿液中检测到的乙型肝炎病毒 DNA 的特征。

DOI：
发表时间：
2018-03-16
期刊：
影响因子：
2.4
作者：
Jain, Surbhi;Su, Ying;Su, Yih;McCloud, Sierra;Xue, Ruixia;Lee, Tai;Lin, Shu;Lin, Selena Y;Song, Wei;Steffen, Jamin D;Hu, Chi
通讯作者：
Hu, Chi

Urine-Based Liquid Biopsy for Nonurological Cancers.

针对非泌尿系统癌症的基于尿液的液体活检。

DOI：
10.1089/gtmb.2018.0189
发表时间：
2019-04-01
期刊：
Genetic testing and molecular biomarkers
影响因子：
0
作者：
Surbhi Jain;Selena Y. Lin;Wei Song;Ying
通讯作者：
Ying

Development and Evaluation of Novel Statistical Methods in Urine Biomarker-Based Hepatocellular Carcinoma Screening.

基于尿液生物标志物的肝细胞癌筛查新统计方法的开发和评估。

DOI：
发表时间：
2018-02-28
期刊：
影响因子：
4.6
作者：
Wang, Jeremy;Jain, Surbhi;Chen, Dion;Song, Wei;Hu, Chi;Su, Ying
通讯作者：
Su, Ying

DNA markers in molecular diagnostics for hepatocellular carcinoma.

肝细胞癌分子诊断中的 DNA 标记。

DOI：
发表时间：
2014-09
期刊：
影响因子：
5.1
作者：
Su, Ying;Lin, Selena Y;Song, Wei;Jain, Surbhi
通讯作者：
Jain, Surbhi

Differential methylation of the promoter and first exon of the RASSF1A gene in hepatocarcinogenesis.

肝癌发生中RASSF1A基因启动子和第一个外显子的差异甲基化。

DOI：
发表时间：
2015-11
期刊：
影响因子：
0
作者：
Jain, Surbhi;Xie, Lijia;Boldbaatar, Batbold;Lin, Selena Y;Hamilton, James P;Meltzer, Stephen J;Chen, Shun;Hu, Chi;Block, Timothy M;Song, Wei;Su, Ying
通讯作者：
Su, Ying