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Predictive Value of Soluble CD146 in Glioblastoma Patients (MUCIGLIO-01)

Primary Purpose

Glioblastoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
plasma collection
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glioblastoma focused on measuring glioblastoma, CD146, bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Adult patients with recurrent IDHwt glioblastoma Relapse after standard first line treatment (radio-chemotherapy) Candidate for bevacizumab treatment Able to be monitored by MRI KPS ≥ 60% Written signed consent form Exclusion Criteria: Pregnancy or breast feeding Life expectancy less than 3 months Bevacizumab in first line treatment Other concomitant life-threatening disease Under legal protection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    plasma collection

    Arm Description

    Plasma samples will be prospectively collected at relevant time points during patient treatment.

    Outcomes

    Primary Outcome Measures

    correlation between soluble CD146 plasma value and patient response (RANO)
    Soluble CD146 plasma value will be assessed using ELISA. Patient response will be evaluated by MRI and clinical response using the international RANO criteria.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 14, 2023
    Last Updated
    August 18, 2023
    Sponsor
    Assistance Publique Hopitaux De Marseille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06001281
    Brief Title
    Predictive Value of Soluble CD146 in Glioblastoma Patients
    Acronym
    MUCIGLIO-01
    Official Title
    Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2025 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique Hopitaux De Marseille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody bevacizumab in recurrent GBM. However, resistance to this anti-angiogenic reagent is frequent and fails to enhance patients' overall survival. The investigators previously identified one novel mechanism responsible for bevacizumab-resistance in CD146-positive glioblastoma (Joshkon et al. Acta Neuropathol Commun, 2022). Now, the investigators objective is to prospectively monitor the soluble CD146 value in plasma from patients treated by bevacizumab for recurrent glioblastoma. The investigators will collect plasma at baseline, before the first bevacizumab administration, before the second administration, at the time of first MRI evaluation and at progression. Plasma CD146 value will be analyzed by ELISA. The investigators expect to confirm the correlation between soluble CD146 value in plasma and patient response to bevacizumab.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioblastoma
    Keywords
    glioblastoma, CD146, bevacizumab

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    55 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    plasma collection
    Arm Type
    Other
    Arm Description
    Plasma samples will be prospectively collected at relevant time points during patient treatment.
    Intervention Type
    Other
    Intervention Name(s)
    plasma collection
    Intervention Description
    Plasma samples will be prospectively collected at relevant time points during patient treatment.
    Primary Outcome Measure Information:
    Title
    correlation between soluble CD146 plasma value and patient response (RANO)
    Description
    Soluble CD146 plasma value will be assessed using ELISA. Patient response will be evaluated by MRI and clinical response using the international RANO criteria.
    Time Frame
    first evaluation (2 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Adult patients with recurrent IDHwt glioblastoma Relapse after standard first line treatment (radio-chemotherapy) Candidate for bevacizumab treatment Able to be monitored by MRI KPS ≥ 60% Written signed consent form Exclusion Criteria: Pregnancy or breast feeding Life expectancy less than 3 months Bevacizumab in first line treatment Other concomitant life-threatening disease Under legal protection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anaïs Maugard
    Phone
    0491435186
    Email
    anais.maugard@ap-hm.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    DRSMR AP-HM
    Email
    promotion.interne@ap-hm.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emeline Tabouret
    Organizational Affiliation
    AP-HM
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Predictive Value of Soluble CD146 in Glioblastoma Patients

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