Predictive Value of Soluble CD146 in Glioblastoma Patients

Glioblastoma Clinical Trial

— MUCIGLIO-01  

Official title:

Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001281
• Other study ID #: RCAPHM23_0011
• Secondary ID: ID RCB
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Emeline Tabouret
• Phone: 0491385500
• Email: emeline.tabouret[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Other:
• plasma collection
Plasma samples will be prospectively collected at relevant time points during patient treatment.

Locations

Country	Name	City	State
France	Service de Neuro-oncologie	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	first evaluation (2 months)