Predictive Value of Soluble CD146 in Glioblastoma Patients

Not Applicable

Recruiting

• Conditions: Glioblastoma
• Interventions: Other: plasma collection

• Registration Number: NCT06001281
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-21
• Study Start: 2024-01-30
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
plasma collection	plasma collection	Plasma samples will be prospectively collected at relevant time points during patient treatment.

Primary Outcome Measures

Name	Time	Method
correlation between soluble CD146 plasma value and patient response (RANO)	first evaluation (2 months)	Soluble CD146 plasma value will be assessed using ELISA. Patient response will be evaluated by MRI and clinical response using the international RANO criteria.

Trial Locations

Locations (1)

Service de Neuro-oncologie; 🇫🇷 Marseille, France