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MUCIGLIO-01: Predictive Value of Soluble CD146 in Glioblastoma Patients

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06001281
Collaborator
(none)
55
Enrollment
1
Arm
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: plasma collection
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: plasma collection

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • Pregnancy or breast feeding

  • Life expectancy less than 3 months

  • Bevacizumab in first line treatment

  • Other concomitant life-threatening disease

  • Under legal protection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Emeline Tabouret, AP-HM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT06001281
Other Study ID Numbers:
  • RCAPHM23_0011
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique Hopitaux De Marseille
glioblastoma
CD146
bevacizumab
Additional relevant MeSH terms:
Glioblastoma

Study Results

No Results Posted as of Aug 22, 2023