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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Mean expression of AR, ER, and other hormone signaling pathway genes in the tumor — Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy
  Expression of AR, ER, and other hormone signaling pathway genes using tumor RNA sequencing data

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France