NCT07829445尚未招募不适用
PRECISE LBCL: Precision Treatment Readiness Through Comprehensive Genomic Sequencing in 1st Line LBCL
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
To determine whether special laboratory tests, called genomic sequencing, can identify specific subtypes of LBCL and provide information that may help guide treatment decisions.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Eligibility Criteria
- •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)
排除标准
- •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.
研究组 & 干预措施
ABC_Subtype
干预措施: Standard of Care (SOC) (Other)
DZsig_Subtype
干预措施: Standard of Care (SOC) (Other)
Other GCB_Subtype
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: 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
次要结局
未报告次要终点
研究者
研究点 (1)
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