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New treatment option for Primary CNS Lymphoma
Official title Diagnosis; Objective RespOnse; THErApy
ClinicalTrials.gov ID: NCT05036564
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- No contraindications to stereotactic or open brain biopsy and lumbar puncture;
- No formal contraindications to intravenous chemo-immunotherapy or whole-brain irradiation;
You likely can't join if
- 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...
- Previous or concurrent malignancies at other sites diagnosed or relapsed within the last 3 years before PCNSL diagnosis. Patients with surgically...
See the full eligibility criteria
- 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.
- 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. 3. Newly...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Italy/Lombardy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Italy/Lombardy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.