2024-519600-27-00招募中2 期
Clinical performance study of a new diagnostic test for drug sensitivity evaluation in metastatic colorectal cancer
Oncosyne AS1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年4月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Proportion of patients with a successful biopsy yielding a µCAN report.
研究概览
简要总结
To evaluate the performance of µCAN to generate high-quality, accurate, robust and reliable data intended as guidance in the physician’s choice for 3rd line therapy for patients with metastatic colorectal cancer.
研究设计
- 分配方式
- Randomized
- 主要目的
- Part B – Exploratory clinical evaluation of µCAN
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give written informed consent (for each part of the study) for participation in the clinical performance study.
- •Male or female patients, ≥18 years of age, with Eastern Cooperative Oncology Group (ECOG) performance status 0-1, who have metastatic lesions in the liver or peritoneum (or lymph nodes) that are radiologically assessable and can be biopsied, and who have recently failed 1st-line systemic therapy (2nd line for patients with three standard therapy lines) for unresectable metastatic disease and will shortly commence a new line of standard therapy.
- •Patient is eligible for another line of tumour directed therapy on failure of the SoC.
- •Patient has the following laboratory values, as measured in serum/plasma within 14 days prior to signing of informed consent for participation in Part A and B, respectively, indicative of adequate organ function: (see protocol for full laboratory values).
排除标准
- •Life expectancy < 3 months.
- •Planned treatment or treatment with another investigational drug or investigational device within 3 months prior to the day of the tumour sampling procedure.
- •Patients who are pregnant, or currently breastfeeding.
- •Investigator considers the patient unlikely to comply with clinical performance study procedures, restrictions and requirements.
结局指标
主要结局
Proportion of patients with a successful biopsy yielding a µCAN report.
Proportion of patients with a successful biopsy yielding a µCAN report.
次要结局
- Proportion of patients with a successful biopsy yielding a µCAN report within 56 days (8 weeks).
- Proportion of patients with a successful biopsy yielding a µCAN report with at least one drug therapy nomination.
- Frequency, intensity and seriousness of adverse events (AEs) related to device or study procedures.
- Frequency and nature of device deficiencies (DD).
- Device user experience questionnaire.
研究者
Information desk
Scientific
Oncosyne AS
研究点 (1)
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