NCT05828628招募中不适用
A Prospective Imaging and Translational Tissue Study in CNS Lymphoma to Enable Further Disease Characterisation and the Development of Potential Predictive and Prognostic Biomarkers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Plasma ctDNA detection
研究概览
简要总结
A prospective imaging and translational tissue study in CNS lymphoma to enable further disease characterisation and the development of potential predictive and prognostic biomarkers.
详细描述
As a single centre exploratory study, this trial will recruit patients with newly diagnosed primary CNS lymphoma and will look at the molecular aspects of the disease in the tissue collection and imaging response assessments using CCA with respect to progression free survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects capable of giving informed consent, or if appropriate, if subject's capacity is deemed limited due to CNS involvement, a consultee can provide consent on their behalf. Some patients with PCNSL may be incapable of providing their own consent due to the neurological effects of their disease. In these cases the patient will be classed as an incapacitated adult and a legal representative will be sought in accordance with English or Scottish law as applicable (see 7.2.1)
- •A radiological or histological diagnosis of primary CNS lymphoma.
- •Have not received prior CNS directed therapy. Prior use of steroids is permitted.
- •Participants aged ≥18 years old.
排除标准
- •Involvement of lymphoma outside of the CNS
结局指标
主要结局
Plasma ctDNA detection
时间窗: 5 Years
To assess if plasma ctDNA detection measured from end of treatment (using the tumour informed approach) can be used an early detection tool for progressive disease.
Contrast clearance analysis
时间窗: 5 Years
To assess the results of contrast clearance analysis
次要结局
- Plasma ctDNA detection rate at disease progression(5 Years)
- Radiological data provided by CCA(5 Years)
- Plasma ctDNA detection rate at baseline(5 Years)
- Plasma ctDNA detection at end of treatment(5 Years)
- Plasma ctDNA detection from end of treatment(5 Years)
研究者
研究点 (1)
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