Clinical trial · Observational
Mathematic Modeling at Micro and Macroscopic Level of Primary Central Nervous System Lymphomas (PCNSL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We plan to analyze 100 PCNSL homogenously treated with high-dose methotrexate based chemotherapy using NGS of PCNSL samples. We will perform DNA-seq and RNA-seq from tumor samples. This data will be combined with their magnetic resonance imaging (MRI) at different time points: at diagnosis, at the end of the treatment and at disease progression. Among the 100 PCNSL that will be included, 70 will be from a retrospective (training set) from patients included in the French National PCNSL dataset (LOC cohort) and 30 PCNSL from a prospective cohort from patients included in a phase III clinical trial (BLOCAGE, PHRC 2014). On the one hand, we will perform a radiomics analysis (quantitative imaging) using 3D tumor and edema segmentation. This analysis will help us to elucidate the potential correlation of MRI phenotypes and genotype (using high-throughput data). In addition, we will use the radiomics data combined with in vitro and in vivo data (using a mouse model of PCNSL) as well as immunohistochemistry data to obtain a multidimensional mathematical modeling of PCNSL clinical evolution that will allow us to better predict the clinical course of this rare subtype of brain tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Central Nervous System Lymphoma (PCNSL) | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor samples and MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Prospective
- interventionNames
- Other: Tumor samples and MRI
- label
- Retrospective
- interventionNames
- Other: Tumor samples and MRI
Primary outcomes (1)
- measure
- Overall survival and progression-free survival modeling using MRI and NGS data in PCNSL patients.
- timeFrame
- 3 years
- description
- PCNSL characterization through the integration of radiomics, gene expression and genotyping features. Mathematic modeling of morphological phenotypes and of prognosis and chemo-sensitivity or chemo-resistance of PCNSL using MRI and NGS data.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion criteria At registration * Newly diagnosed primary cerebral lymphoma * Age ≥60 years * Pathology proven diagnosis or positive cytology of the CSF or vitreous * Karnofsky Performance Status ≥40 * No evidence of systemic NHL (body CT scan, bone marrow biopsy) * Adequate haematological, renal and hepatic function * Calculated creatinine clearance \> 40 ml/min At randomization * Complete response on MRI after induction chemotherapy according to the IPCG criteria (Abrey et al, 2005) * Karnofsky Performance Status ≥40 * Adequate haematological, renal and hepatic function Exclusion criteria * Positive HIV serology * Preexisting immunodeficiency (organ transplant recipient) * Prior treatment for PCNSL * Isolated primary intra-ocular lymphoma * Low grade lymphoma * Any other active primary malignancy
References
Publications (0)
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