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RecruitingNCT06001281MUCIGLIO-01Updated Feb 2, 2024

Predictive Value of Soluble CD146 in Glioblastoma Patients

An interventional study of plasma collection in Glioblastoma, sponsored by Assistance Publique Hopitaux De Marseille. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glioblastoma

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Keywords

  • glioblastoma
  • CD146
  • bevacizumab
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 55 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Other
    plasma collection

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

    Other: plasma collection

Interventions

  • Otherplasma collection

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

06

What researchers measure

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.

    Time frame: first evaluation (2 months)

07

Study locations

1 of 1 sites recruiting
  • Service de Neuro-oncologie
    Marseille, 13005, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06001281
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Aug 21, 2023
Start date
Jan 30, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Feb 2, 2024

Study contacts

Emeline Tabouret
Contact
emeline.tabouret@ap-hm.fr
0491385500 ext. 33
DRSMR AP-HM
Contact
promotion.interne@ap-hm.fr
Emeline Tabouret
principal investigator · AP-HM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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