Mathematic Modeling at Micro and Macroscopic Level of Primary Central Nervous System Lymphomas (PCNSL)

NCT04253496 | Unknown

• 2 other identifiers: PRTK161492014-002597-37
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Primary Central Nervous System Lymphoma (PCNSL)

Keywords

PCNSL; Mathematical modeling; Next-generation sequencing; Radiomics

Outcome Measures

Primary Outcomes (1)

• Overall survival and progression-free survival modeling using MRI and NGS data in PCNSL patients.

  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.

  3 years

Secondary Outcomes (1)

• PCNSL progression modeling.

  3 years

Study Arms (2)

Prospective

Other: Tumor samples and MRI

Retrospective

Other: Tumor samples and MRI

Interventions

Tumor samples and MRI OTHER

We will use DNA and RNA tumor samples. We will not use germline or blood DNA. These data will be combined with their magnetic resonance imaging (MRI) at different times: at diagnosis, at the end of treatment and at the progression of the disease.

Prospective; Retrospective

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PCNSL at diagnosis, before chemotherapy with available fresh-frozen tissue, MRI and clinical follow-up

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier La Pitié Salpêtrière

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor DNA and RNA

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Khê HOANG-XUAN, MD, PhD

  Groupe Hospitalier La Pitié Salpêtrière - AP-HP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: May 12, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

FR (1)