Predictive Value of Soluble CD146 in Glioblastoma Patients

NCT06001281 | Recruiting

• 2 other identifiers: RCAPHM23_0011ID RCB
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

glioblastoma; CD146; bevacizumab

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

plasma collection

OTHER

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

Other: plasma collection

Interventions

plasma collection OTHER

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

plasma collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• Pregnancy or breast feeding
• Life expectancy less than 3 months
• Bevacizumab in first line treatment
• Other concomitant life-threatening disease
• Under legal protection

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service de Neuro-oncologie

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Emeline Tabouret

  AP-HM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emeline Tabouret

CONTACT

0491385500; emeline.tabouret@ap-hm.fr

DRSMR AP-HM

CONTACT

promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: January 30, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 2, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)