Predictive Value of Soluble CD146 in Glioblastoma Patients

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06001281
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assistance Publique Hopitaux De Marseille
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Emeline Tabouret
Principal Investigator Affiliation AP-HM
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Other: plasma collection

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

Interventions

Other: - plasma collection

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

Contact a Trial Team

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International Sites

Service de Neuro-oncologie, Marseille, France

Status

Recruiting

Address

Service de Neuro-oncologie

Marseille, , 13005

Site Contact

TABOURET Emeline

[email protected]

0491385500 #33

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