Qualifying Multi-Transcript Signatures for Active Surveillance of Prostate Cancer

用于前列腺癌主动监测的合格多转录本签名

基本信息

批准号：
9307744
负责人：
HYUNG L KIM
金额：
$ 49.58万
依托单位：
CEDARS-SINAI MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-02 至 2019-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9307744
关键词：
Address Adverse effects African American Biological Assay Biological Markers Biological Sciences Biopsy Biopsy Specimen CLIA certified Cancer Etiology Caucasians Cessation of life Clinical Data Data Set Diagnosis Diagnostic Disease Disease Progression Enrollment Ethnic Origin Ethnic group Extracapsular Gene Chips Glare Gleason Grade for Prostate Cancer Goals Guidelines Histologic Laboratories Laboratory Study Leadership Local Therapy Louisiana Malignant Neoplasms Malignant neoplasm of prostate Measurement Medical center Metastatic Neoplasm to Lymph Nodes Modernization Molecular Natural History Needle biopsy procedure Neoplasm Metastasis Newly Diagnosed North Carolina Oligonucleotide Microarrays Oligonucleotides Operative Surgical Procedures Outcome Pathologic Pathology Patients Performance Population Surveillance Positioning Attribute Professional Organizations Prostate Prostatectomy Prostatic Neoplasms Public Health Qualifying Quality of life RNA Radiation therapy Radical Prostatectomy Research Personnel Risk Risk stratification Roswell Park Cancer Institute Sampling Seminal Vesicles Severities Specimen Testing Time Training Transcript Translating Universities Validation adverse outcome base cancer diagnosis cancer risk cohort computerized data processing density disorder risk ethnic difference genetic signature high risk improved outcome men outcome forecast outcome prediction performance tests predictive signature prognostic prognostic assays prostate biopsy public health relevance specific biomarkers tool transcriptomics

项目摘要

DESCRIPTION (provided by applicant): The vast majority of men diagnosed with prostate cancer do not die of their disease and can choose to delay or avoid surgical or radiation treatment by undergoing active surveillance. Patients diagnosed with prostate cancer that is categorized as low risk are ideal candidates for active surveillance. Unfortunately, clinical and pathologic parameters available at the time of diagnosis will understage or undergrade prostate cancer in approximately 1/3 of all cases. Therefore, better strategies are needed to risk-stratefy newly diagnosed, low risk prostate cancer. The goal of the proposed project is to evaluate existing RNA-based multi-analyte signatures for risk-stratification at the time of prostate cancer diagnosis. To address the glaring absence of well-established criteria for active surveillance in non-Caucasian men, the validation is performed in parallel in separate Caucasian and African-American cohorts. The project consists of an academic-commercial partnership between Cedars-Sinai Medical Center, Johns Hopkins, University of Toronto, Roswell Park Cancer Institute, and GenomDx Biosciences. The consortium will evaluate signatures trained and tested in large numbers of prostatectomies and confirmed to be predictive of adverse prostate cancer pathology and disease progression. It is now clear that majority of patients who have undergone prostatectomy in the past are candidates for active surveillance; therefore, signatures from prostatectomies are likely to be relevant to diagnostic biopsies from modern active surveillance candidates. The specific aims are (1) to validate biomarkers in prostate needle biopsies predictive of adverse pathology and progression in men considering active surveillance and (2) to test the effects of African-American ethnicity on the biomarker signatures. The consortium is well-positioned to rapidly translate and promote validated signatures since all assays will be performed in a CLIA-approved laboratories, and study investigators have leadership positions in cooperative groups, national professional societies, and national guidelines committees.

描述（由申请人提供）：绝大多数被诊断患有前列腺癌的男性并未死于该病，并且可以通过主动监测选择延迟或避免手术或放射治疗。被诊断为低风险前列腺癌的患者是主动监测的理想候选人。不幸的是，在大约 1/3 的病例中，诊断时可用的临床和病理参数无法对前列腺癌进行分期或降级。因此，需要更好的策略来对新诊断的低风险前列腺癌进行风险策略。该项目的目标是评估现有的基于 RNA 的多分析物特征，以便在前列腺癌诊断时进行风险分层。为了解决非白人男性主动监测明显缺乏完善标准的问题，验证是在单独的白人和非裔美国人队列中并行进行的。该项目由 Cedars-Sinai 医疗中心、约翰·霍普金斯大学、多伦多大学、罗斯威尔帕克癌症研究所和 GenomDx Biosciences 之间的学术-商业合作伙伴关系组成。该联盟将评估在大量前列腺切除术中训练和测试的特征，并证实可以预测不良前列腺癌病理和疾病进展。现在很清楚，大多数过去接受过前列腺切除术的患者都是主动监测的候选者；因此，前列腺切除术的特征可能与现代主动监测候选者的诊断活检有关。具体目标是（1）验证前列腺穿刺活检中的生物标志物，以预测男性考虑主动监测的不良病理和进展；（2）测试非裔美国人种族对生物标志物特征的影响。该联盟处于有利地位，可以快速翻译和推广经过验证的签名，因为所有测定都将在 CLIA 批准的实验室中进行，并且研究调查人员在合作团体、国家专业协会和国家指南委员会中担任领导职务。