UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch: Hoosier Cancer Research Network GU15-217
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 14
- 主要终点
- Proportion of subjects who receive NGS and have a personalized report generated with potential treatment options
研究概览
简要总结
This comprehensive genomic analysis and biospecimen repository study incorporates Next Generation Sequencing (NGS) of archival tumor tissue from 200 subjects with metastatic urothelial cancer in support of several parallel goals. The immediate goal involves generation of a comprehensive report identifying subject specific genetic mutations and/or alterations based on NGS. Additionally, DNA and RNA extracted from tumor specimens and any remaining blocks/slides from the NGS will be stored for future research. Long-term, the goal of this endeavor is to support collaborative translational research projects in metastatic urothelial cancer by allowing investigators to interrogate abstracted coded clinical data linked to data from any biospecimen studies.
详细描述
OUTLINE: This is a multi-center study.
STUDY PLAN:
SUBJECT IDENTIFICATION AND CONSENT:
Sites may approach all subjects who attend an appointment for evaluation of metastatic urothelial cancer for inclusion. Study staff review consent documents with potential subjects and answer any and all questions. If a subject desires additional time or wishes to delay enrollment in the study, he/she is given a copy of the consent document and informed about how to ask questions or enroll at a later date. If the subject chooses to participate in the study, he or she signs the consent, and is given a copy for his or her own records.
BIOSPECIMEN COLLECTION AND PROCESSING:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following applicable inclusion criteria to participate in this study:
- •IRB-approved written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- •Age ≥ 18 years at the time of consent.
- •Histologically or cytologically confirmed urothelial cancer of the bladder, urethra, ureter, or renal pelvis.
- •Metastatic urothelial cancer as defined by M1 (distant metastatic disease) and/or N3 (nodes outside of the true pelvis) at the time of registration.
- •Tumor tissue available and suitable for molecular analyses from at least one of the following sources:
- •Tissue previously stored at enrolling institution
- •Tissue previously stored at an outside institution (other than enrolling institution)
- •The tissue specimen may come in the form of a block or slides accessed under UC-GENOME from enrolled subjects. Needle biopsy is also acceptable. Details regarding collection requirements, processing and shipping can be found in the Correlative Laboratory Manual (CLM).
- •Willing to provide access to tissue and blood for future research, including genetic studies.
排除标准
- •Subjects meeting any of the criteria below may not participate in the study:
- •Unwilling or unable to provide informed consent.
- •Affected by dementia, altered mental status, or any psychiatric or co-morbid condition that would prohibit the understanding or rendering of informed consent, as determined by treating physician.
结局指标
主要结局
Proportion of subjects who receive NGS and have a personalized report generated with potential treatment options
时间窗: From date of consent to receipt of NGS report (estimate 14 days)
Subject-specific report that includes a summary of genomic alterations and potential therapeutic options based on the specific alterations and evidence discovered.
Collection of tissue and blood samples from subjects receiving treatment for urothelial cancer
时间窗: From date of consent and retained indefinitely (estimate 10 years)
Tissue and blood samples will be preserved and stored in a biorepository that cancer investigators can access for future IRB approved translational studies
次要结局
- Collect comprehensive demographic data for all subjects enrolled in this clinical trial(From date of consent until end of therapy (assessed up to 2 years))
- Collect comprehensive clinical outcomes for all subjects enrolled in this clinical trial(From date of consent until end of therapy (assessed up to 2 years))
- Research projects resulting from biospecimen and data repository(From study close until all biospecimens and data have been utilized (estimate 10 years))
- Collect comprehensive treatment histories for all subjects enrolled in this clinical trial(From date of consent until end of therapy (assessed up to 2 years))
- Overall Survival (OS)(From treatment initiation until death as a result of any cause, up to 60 months)
- Proportion of subjects whose personalized NGS report includes targeted therapy treatment options(From date of consent to receipt of NGS report by treating physician (estimate 14 days))
- Proportion of subjects whose personalized NGS report includes potential clinical trial options(From date of consent to receipt of NGS report by treating physician (estimate 14 days))
- Proportion of subjects who receive targeted therapy(From date of consent to receipt of NGS report by treating physician (estimate 14 days))
研究者
Matthew Milowsky, MD
Sponsor-Investigator
Hoosier Cancer Research Network