NCT06878131招募中不适用
Precision-MRD: Prospective Observational Study of Biomarker-directed Systemic Therapy for Colorectal Cancer Patients With Minimal Residual Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Safety and Adverse events (AEs)
研究概览
简要总结
The goal of this clinical research study is to learn about the effects of biomarkertargeted therapy on ctDNA in patrticipants with CRC and MRD.
This is an observational study. Participants will be monitored while receiving biomarker-directed therapy that is determined by your treating oncologist (cancer doctor) per standard of care, independent of this study.
详细描述
Primary Objective
• To estimate the rate of ctDNA clearance at 6 months following initiation of biomarker-directed targeted therapy in colorectal cancer (CRC) participants with minimal residual disease (MRD).
Secondary Objectives
- To evaluate dynamics of ctDNA mutant allele fractions following initiation of biomarker-directed targeted therapy in MRD-positive CRC participants.
- To estimate the rate of disease recurrence at 1 year following initiation of biomarker-directed targeted therapy in MRD-positive CRC participants.
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
- •Male or female subjects aged > 18 years.
- •Histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma.
- •Stage II-IV disease per current AJCC staging criteria with no definitive radiographic evidence of disease following locoregional treatment. Small indeterminate lesions measuring < 10 mm may be permitted at the discretion of the principal investigator.
- •Presence of one of the following targetable biomarkers on tumor or blood molecular testing: BRAF V600E mutation (Cohort A), KRAS G12C mutation (Cohort B), MSI-H status (Cohort C), and HER2 amplification (Cohort D).
- •Positive ctDNA blood test obtained > 21 days after surgery or last administration of adjuvant therapy.
- •Prescribed one of the following standard-of-care targeted therapy regimens: BRAF V600E Inhibitor + anti-EGFR antibody for BRAF V600E-mutated tumors, KRAS G12C Inhibitor + anti-EGFR antibody for KRAS G12C-mutated tumors, anti-PD-1 antibody +/- anti-CTLA-4 antibody for MMRd/MSI-H tumors, or anti-HER2 therapies for HER2 amplified tumors.
排除标准
- •Prior exposure to the following classes of biomarker-directed therapies: BRAF V600E inhibitors, anti-EGFR antibodies, KRAS G12C inhibitors, anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or anti-HER2 therapies
- •Presence of a concurrent malignancy requiring active treatment
- •Inability to provide informed consent
- •Children will not be enrolled in this study
- •Pregnant women will not be enrolled in this study
- •Cognitively Impaired subjects will not be enrolled in this study
结局指标
主要结局
Safety and Adverse events (AEs)
时间窗: Through study completion; an average of 1 year.
次要结局
未报告次要终点
研究者
研究点 (2)
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