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
About this trial
This is an interventional basic science trial for Glioblastoma focused on measuring glioblastoma, CD146, bevacizumab
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
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
NCT ID
NCT06001281
First Posted
August 14, 2023
Last Updated
August 18, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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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