Diagnosis; Objective RespOnse; THErApy
ConditionPrimary CNS Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lumbar puncture
Procedure/SurgeryA lumbar puncture (spinal tap) is performed in patient lower back, in the lumbar region. During a lumbar puncture, a needle is inserted between two lumbar bones (vertebrae) to remove a sample of cerebrospinal fluid (CSF). This is the fluid that surrounds brain and spinal cord to protect them from injury. This procedure is usually performed at the time of diagnosis for disease staging and/or repeated in the course of the disease history, only if positive or for clinical reasons (i.e. suspicious of relapse progression). In this study sequential CSF and peripheral blood samples of study population will be collected also at different time points, with the aim to improve diagnostics sensitivity, response assessment and monitoring early CNS relapse.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Study population - PCNSLExperimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Association between recurrent genetic alterations and PCNSL diagnosis or relapse
Frequency of various genetic mutations among enrolled patients at diagnosis or relapse
Time frame
3 years and 6 months2
Association between recurrent genetic alterations and residual enhanced and not-enhanced images at the MRI
Frequency of various genetic mutations among enrolled patients during treatment
Time frame
3 years and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov