Impact of Androgen Signaling on the Composition of the Immune Microenvironment in Glioblastomas

NCT07472387 | Not Yet Recruiting

• 1 other identifier: APHP241106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Glioblastoma (GBM) is the most common and most aggressive primary brain cancer in adults. GBM is more common in men than in women, with a male-to-female ratio of 1.6. Furthermore, being male is associated with a poorer prognosis. These data suggest that sex and/or sexual hormones and more specifically androgens may play a role in the initiation, the growth, and the resistance to treatments of GBM.

Conditions

Glioblastoma (GBM)

Keywords

Glioblastoma; Androgen

Outcome Measures

Primary Outcomes (1)

• Mean expression of AR, ER, and other hormone signaling pathway genes in the tumor

  Expression of AR, ER, and other hormone signaling pathway genes using tumor RNA sequencing data

  Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy

Secondary Outcomes (3)

• Mean of Percentage of immunosuppressive cells measured at T1 and T2 in the blood and tumor

  Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy

• Profile of immunosuppressive cytokines in the tumor

  Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy

• Mean of the Proportion of intratumoral immune cells

  Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy

Study Arms (1)

Glioblastoma patients

EXPERIMENTAL

Adult men and women with GBM who are being treated in the neuro-oncology department at La Pitié-Salpêtrière Hospital.

Other: blood sampling; Other: saliva sampling; Other: stool sampling; Other: Tumor sampling

Interventions

blood sampling OTHER

Additional blood samples (in addition to those taken as part of treatment) will be taken from patients at T1 (before any medical treatment) and at T2 (one month after the end of concomitant chemoradiotherapy). These samples, totaling 6 to 8 mL, will be taken between 9 a.m. and 11 a.m. (this time slot allows patients to normalize their circadian rhythm)

Glioblastoma patients

saliva sampling OTHER

During these same visits at T1 and T2, a saliva sample will be collected using Salivette® Cortisol saliva collection devices (UGAP ref.: 2745674)

Glioblastoma patients

stool sampling OTHER

During these same visits at T1 and T2, a stool sample will be collected by the patient using the kit (Stool Sample Collection Kit with Stool Catcher, Canvax)

Glioblastoma patients

Tumor sampling OTHER

At the time of surgery performed as part of treatment (before T1), tumor tissue from the surgical waste will be collected.

Glioblastoma patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged ≥18 and ≤55
• Newly diagnosed GBM
• Surgery with complete or incomplete resection
• Eligible for chemoradiotherapy
• No active immune disorders
• Supratentorial location on MRI and no signs of meningeal dissemination
• Tumor sample (taken as part of treatment) available for study (fresh frozen tissue)
• Patient informed and consented to participate in the study
• Affiliation with a social security system or beneficiary

You may not qualify if:

• Active infection at the time of sampling or within the previous 14 days
• Active immune disorders
• Known patients with low-grade glioma that has undergone anaplastic transformation
• Patients treated with corticosteroids
• Patients participating in interventional research
• Patients under legal protection, guardianship, or conservatorship.
• Pregnant or breastfeeding women
• Individuals under AME

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Neuro-oncology department, Pitié Salpêtrière hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ahmed IDBAIH, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed IDBAIH, MD-PhD

CONTACT

01 42 16 03 85; ahmed.idbaih@aphp.fr

Maïté VERREAULT, PhD

CONTACT

01 57 27 43 91; maite.verreault@icm-institute.org

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: February 16, 2026
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)