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

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ClinicalTrials.gov Identifier: NCT04253496
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Primary Central Nervous System Lymphoma (PCNSL) Other: Tumor samples and MRI

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Mathematic Modeling at Micro and Macroscopic Level of Primary Central Nervous System Lymphomas (PCNSL)
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : September 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort Intervention/treatment
Prospective Other: Tumor samples and MRI
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.

Retrospective Other: Tumor samples and MRI
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.




Primary Outcome Measures :
  1. Overall survival and progression-free survival modeling using MRI and NGS data in PCNSL patients. [ Time Frame: 3 years ]

    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 Outcome Measures :
  1. PCNSL progression modeling. [ Time Frame: 3 years ]
    Analysis chemo-resistance pathways and development of new therapeutic targets in PCNSL using integrative data: mouse model of PNCSL, in vitro data and radiomics analysis.


Biospecimen Retention:   Samples With DNA
Tumor DNA and RNA


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PCNSL at diagnosis, before chemotherapy with available fresh-frozen tissue, MRI and clinical follow-up
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253496


Contacts
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Contact: Khê HOANG-XUAN, MD, PhD 01.42.16.03.81 khe.hoang-xuan@aphp.fr
Contact: Agusti ALENTORN, MD, PhD agusti.alentorn@aphp.fr

Locations
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France
Groupe Hospitalier La Pitié Salpêtrière
Paris, France, 75013
Contact: Khê HOANG-XUAN, MD, PhD    01.42.16.03.81    khe.hoang-xuan@aphp.fr   
Contact: Agusti ALENTORN, MD, PhD       agusti.alentorn@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Khê HOANG-XUAN, MD, PhD Groupe Hospitalier La Pitié Salpêtrière - AP-HP
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04253496    
Other Study ID Numbers: PRTK16149
2014-002597-37 ( EudraCT Number )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
PCNSL
Mathematical modeling
Next-generation sequencing
Radiomics
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases