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NCT Number: NCT06001281

Predictive Value of Soluble CD146 in Glioblastoma Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neuro-oncologie

Marseille, 13005, France

Location status: Recruiting

Location contact

TABOURET Emeline

CONTACT

[email protected]

0491385500 ext. 33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma Collection

Other

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

Primary outcomes

  1. correlation between soluble CD146 plasma value and patient response (RANO)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

DRSMR AP-HM

CONTACT

[email protected]

Emeline Tabouret

CONTACT

[email protected]

0491385500 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: MUCIGLIO-01

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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