Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Patients in whom actionable alterations were identified in ctDNA analysis
研究概览
简要总结
The goal of this study is to assess the implementation and feasibility of ctDNA measurements from blood samples obtained during routine clinical care of cancer patients in the University Hospital Basel.
Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements (external comparator from registry AO_2023-00091).
Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples.
详细描述
Liquid biopsies, in particular the analysis of circulating tumor DNA (ctDNA), have emerged as a promising tool for detecting and monitoring cancer. Measuring ctDNA in patients with solid malignancies may help to identify targetable alterations, measure disease burden, identify early mutations of resistance, tailor and deescalate cancer treatment, and predict patient prognosis. Although the adoption and application of ctDNA measurements for patients with solid tumors in routine clinical care is increasing, evidence supporting the integration of ctDNA into current practice is limited, especially for patients with advanced cancers.
This is a trial using routinely collected health care data from an ongoing registry (AO_2023-00091) in cancer patients with advanced solid malignancies receiving first line systemic anticancer treatment for advanced disease.
This trial will assess the feasibility and implementation of routine measurement of ctDNA and its association with clinical outcomes, including quality of life and survival. All patients will receive routine diagnostics, treatment and follow-up. All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry. We will then randomly decide which eligible patients are invited to participate in the trial. If patients accept the invitation and intend to get a measurement of ctDNA, they have to provide written informed consent.
Results from ctDNA analyses will be discussed at the molecular tumor board, an established regular interdisciplinary meeting at the University Hospital Basel (part of routine care) to discuss patients with complex findings from tumor sequencing analyses. Treatment changes occurring during the trial duration will be at the discretion of treating physician and according to patient's preference as is routine standard of care.
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
- •Patients with a proven solid malignant disease, i.e. with solid malignant tumors where no primary surgical resection is planned OR solid malignant tumors that are locally advanced and inoperable OR solid tumors that are metastatic
- •No prior treatment for advanced/metastatic disease
- •Indication for medical anti-cancer treatment (including combined chemoradiotherapy) as judged by the treating physician
- •Patient age 18 years and older
- •General research consent of the University Hospital Basel
排除标准
- •● Patients with primary brain tumors
研究组 & 干预措施
Active Comparator
Patients included in the ongoing registry AO_2023-00091.
Patients will have ctDNA measurements being performed on blood samples collected as part of clinical routine.
干预措施: ctDNA measurement (Diagnostic Test)
结局指标
主要结局
Patients in whom actionable alterations were identified in ctDNA analysis
时间窗: baseline, between month 2 and 3, between month 5 and 6, clinical event
Patients in whom actionable alterations were identified in ctDNA analysis. Calculated as the number of patients with actionable alterations over the total number of patients included, expressed as a percentage. Clinical event is defined as suspicious or confirmed clinical or radiological disease progression or treatment discontinuation for any reason.
Turn-around time of ctDNA analysis
时间窗: baseline, between month 2 and 3, between month 5 and 6, clinical event
Time from ctDNA request until issuing the first report. Expressed as hours. Clinical event is defined as suspicious or confirmed clinical or radiological disease progression or treatment discontinuation for any reason.
Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment
时间窗: 1 time assessment at baseline
Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment. Calculated as the number of patients with detectable ctDNA over the total number of patients included, expressed as a percentage.
ctDNA kinetics
时间窗: up to 24 months
Change in allelic frequency over time including relative changes from baseline.
次要结局
- Unplanned hospital admissions and emergency room visits(up to 24 months)
- Survival rate 12 months(Month 12)
- Time to next treatment line(up to 24 months)
- Survival rate 6 months(Month 6)
- Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential(up to 24 months)
- Number of ctDNA analyses with a valid result(up to 24 months)
- Number of ctDNA testing results that were successfully made available to the molecular tumor board(up to 24 months)
- Progression free survival(up to 24 months)
- Quality of life and physical function(month 3, month 6, month 12)
- Overall survival(up to 24 months)