Clinical trial · NCT07472387 · NOT_YET_RECRUITING · NA
Impact of Androgen Signaling on the Composition of the Immune Microenvironment in Glioblastomas
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
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)
- 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)
- 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)
- Tumor sampling · OTHER
At the time of surgery performed as part of treatment (before T1), tumor tissue from the surgical waste will be collected.
Published eligibility criteria
Verbatim from the registry. Only the site can decide how these apply to a specific patient.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Sites (1)
- Neuro-oncology department, Pitié Salpêtrière hospital, Paris, France
Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-03-16.