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

ConditionGlioblastoma (GBM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥18 and ≤55

Newly diagnosed GBM

Surgery with complete or incomplete resection

Eligible for chemoradiotherapy

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • blood sampling

    Other intervention

    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 intervention

    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 intervention

    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 intervention

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Glioblastoma patientsExperimental treatment 4 interventions

Trial outcomes

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

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

Secondary outcomes

1

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

Percentage of immunosuppressive cells measured at T1 and T2 in the blood and tumor using spectral cytometry

Time frame
Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy
2

Profile of immunosuppressive cytokines in the tumor

Profile of immunosuppressive cytokines in the tumor (quantification of a panel of cytokines)

Time frame
Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy
3

Mean of the Proportion of intratumoral immune cells

Proportion of intratumoral immune cells via the deconvolution of tumor RNA sequencing data

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: