| NCT ID | NCT05036564 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Primary CNS Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2020-10-16 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2020-10-16 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria for study population: 1. Age ≥18 years 2. Newly diagnosed PCNSL with available clinical and radiological data, CSF and histopathological brain biopsy material fresh and/or formalin fixed and paraffin embedded; 3. No contraindications to stereotactic or open brain biopsy and lumbar puncture; 4. No formal contraindications to intravenous chemo-immunotherapy or whole-brain irradiation; 5. 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 study population: 1. Patients with concomitant CNS and systemic involvement at presentation (potentially eligible as "control"; see below) 2. Patients with CNS lymphoma other than DLBCL subtype 3. Any other serious medical condition which could impair the ability of the patient to participate in the trial 4. Pregnant and lactating female patients. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation. 5. 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. 6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Inclusion criteria for controls: 1. Age ≥18 years 2. 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. 3. Newly diagnosed and/or relapsed SCNSL with available clinical and radiological data, CSF and diagnostic histopathological specimen. 4. Newly diagnosed lymphoma confined to CNS other than DLBC subtype 5. 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. 6\. No contraindications to stereotactic or open brain biopsy and lumbar puncture; 7. 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: 1. Patients with extra-CNS lymphoma other than DLBC or HGBC subtypes, and not classified as high risk of CNS relapse; 2. Any other serious medical condition which could impair the ability of the patient to participate in the trial; 3. Pregnant and lactating female patients. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation; 4. 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; 5. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Contact & Investigator
Andrés J.M. Ferreri, MD
PRINCIPAL INVESTIGATOR
IRCCS Ospedale San Raffaele
Frequently Asked Questions
Who can join the NCT05036564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary CNS Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05036564 currently recruiting?
Yes, NCT05036564 is actively recruiting participants. Contact the research team at ferreri.andres@hsr.it for enrollment information.
Where is the NCT05036564 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05036564 clinical trial?
NCT05036564 is sponsored by IRCCS San Raffaele. The principal investigator is Andrés J.M. Ferreri, MD at IRCCS Ospedale San Raffaele. The trial plans to enroll 70 participants.