PRECISE LBCL: Precision Treatment Readiness Through Comprehensive Genomic Sequencing in 1st Line LBCL
To determine whether special laboratory tests, called genomic sequencing, can identify specific subtypes of LBCL and provide information that may help guide treatment decisions.
研究概览
详细说明
Primary Objectives
• To determine the proportion of patients whose BostonGene Tumor Portrait Molecular Test results are available to the treating physician by the start of Cycle 2 of standard-ofcare anthracycline-based therapy
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Dai Chihara, MD
- 电话号码：713-563-4354
- 邮箱：JMDennison@mdanderson.org
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- 招聘中
- UT MD Anderson Cancer Center
-
首席研究员：
- Dai Chihara, MD
-
接触：
- Dai Chihara, MD
- 电话号码：713-563-4354
- 邮箱：JMDennison@mdanderson.org
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
MD Anderson Cancer Center
描述
Eligibility Criteria
- Age ≥18y
- Pathology-confirmed diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma (HGBL) who are eligible for standard-of-care, full-dose 6 cycles of anthracycline-based treatment
- Stage 3 or 4 disease by Lugano Criteria
- Available biopsy sample for BostonGene Tumor Portrait™ test ( for sample preparation)
Exclusion Criteria
- Known central nervous system (CNS) disease (cases concerning for CNS involvement should be evaluated with MRI and lumbar puncture)
- Any baseline characteristics that in the opinion of the treating physician would preclude patients from receiving standard-of-care anthracycline-based treatment
- Participation (or planning to participate) in any therapeutic clinical trials for lymphoma during the planned treatment course. Note, patients who become eligible for other studies based on inadequate response, toxicity to therapy, or other reasons that arise after the initiation of standard therapy on this study are permitted to pursue those alternative trials as appropriate. Participation in other non-therapeutic and/or observational studies are permitted.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
ABC_Subtype
|
Standard of care |
|
DZsig_Subtype
|
Standard of care |
|
Other GCB_Subtype
|
Standard of care |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety and adverse events (AEs)
大体时间：Through study completion; an average of 1 year.
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Through study completion; an average of 1 year.
|
合作者和调查者
调查人员
- 首席研究员：Dai Chihara, MD、UT MD Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025-1674
- NCI-2026-06976 (其他标识符：NCI-CTRP Clinical Registry)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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