NCT05036564招募中不适用
Mutational Analysis in the Cerebrospinal Fluid to Improve Diagnostic Sensitivity, Response Definition and Precision Treatment in Primary Central Nervous System Lymphoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Association between recurrent genetic alterations and PCNSL diagnosis or relapse
研究概览
简要总结
Thi is a prospective and low-intervention clinical trial. We propose to design a panel of "core" genetic alterations by sequencing Cerebral Spinal Fluid (CSF) DNA in patients with confirmed or suspicious Primary Central Neurvous System Lymphoma (PCNSL) with the aim to improve diagnostic sensitivity, response assessment and monitoring early CNS relapse in routine practice.
Enrolled patients will receive conventional treatments according to well-established international guidelines, DNA assessments will not influence the treatment choices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •for study population:
- •Age ≥18 years
- •Newly diagnosed PCNSL with available clinical and radiological data, CSF and histopathological brain biopsy material fresh and/or formalin fixed and paraffin embedded;
- •No contraindications to stereotactic or open brain biopsy and lumbar puncture;
- •No formal contraindications to intravenous chemo-immunotherapy or whole-brain irradiation;
- •Given written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without any prejudice.
排除标准
- •for study population:
- •Patients with concomitant CNS and systemic involvement at presentation (potentially eligible as "control"; see below)
- •Patients with CNS lymphoma other than DLBCL subtype
- •Any other serious medical condition which could impair the ability of the patient to participate in the trial
- •Pregnant and lactating female patients. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation.
- •Previous or concurrent malignancies at other sites diagnosed or relapsed within the last 3 years before PCNSL diagnosis. Patients with surgically cured in situ carcinomas and basal cell carcinoma of the skin are allowed.
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Inclusion criteria for controls:
- •Age ≥18 years
- •Newly diagnosed DLBCL with a high risk for relapse/progression in the CNS or High-grade B-cell (HGBC) lymphoma with available clinical and radiological data, CSF and diagnostic histopathological specimen.
- •Newly diagnosed and/or relapsed SCNSL with available clinical and radiological data, CSF and diagnostic histopathological specimen.
- •Newly diagnosed lymphoma confined to CNS other than DLBC subtype
- •Neoplastic and non-neoplastic neurological disorders (neurodegenerative and neuroinflammatory disorders, toxic or infective encephalitis, primary CNS tumors other than lymphomas (mainly gliomas)) with available clinical and radiological data, CSF samples and, where possible, histo-pathological brain biopsy material formalin fixed and paraffin embedded.
- •No contraindications to stereotactic or open brain biopsy and lumbar puncture;
- •Given written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without any prejudice.
- •Exclusion criteria for controls:
- •Patients with extra-CNS lymphoma other than DLBC or HGBC subtypes, and not classified as high risk of CNS relapse;
- •Any other serious medical condition which could impair the ability of the patient to participate in the trial;
- •Pregnant and lactating female patients. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation;
- •Previous or concurrent malignancies at other sites diagnosed or relapsed within the last 3 years of follow-up. Patients with surgically cured in situ carcinomas and basal cell carcinoma of the skin are allowed;
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究组 & 干预措施
Study population - PCNSL
Experimental
Patients (pts) with clinical and radiological suspicion of PCNSL or with confirmed diagnosis of PCNSL will be enrolled to the protocol. They will represent the "Study population"
干预措施: Lumbar puncture (Procedure)
Control
Other
- Pts with suspicion of secondary CNS lymphoma, that includes subjects with DLBCL and involvement of the CNS at presentation in association with systemic disease, or subjects with systemic DLBCL and CNS relapse during or after primary therapy.
- Pts with histological diagnosis of systemic DLBCL at high risk of CNS relapse according to Institutional guidelines and patients with histological diagnosis of systemic high grade B cell lymphoma, according to 2017 WHO classification;
- pts affected by neurological disorders that are usually differential diagnosis of PCNSL (i.e. neurodegenerative and neuroinflammatory disorders, toxic or infective encephalitis, other primary CNS tumors).
干预措施: Lumbar puncture (Procedure)
结局指标
主要结局
Association between recurrent genetic alterations and PCNSL diagnosis or relapse
时间窗: 3 years and 6 months
Frequency of various genetic mutations among enrolled patients at diagnosis or relapse
Association between recurrent genetic alterations and residual enhanced and not-enhanced images at the MRI
时间窗: 3 years and 6 months
Frequency of various genetic mutations among enrolled patients during treatment
次要结局
未报告次要终点
研究者
Andrés José Maria Ferreri
Principal Investigator; Lymphoma Unit, Head
IRCCS San Raffaele
研究点 (1)
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