Glioblastoma (GBM)Andro-iGlioNCT07472387
Impact of Androgen Signaling on the Composition of the Immune Microenvironment in Glioblastomas
A study testing blood sampling, saliva sampling and stool sampling in people with Glioblastoma (GBM), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- blood sampling, saliva sampling and stool sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 1 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Neuro-oncology department, Pitié Salpêtrière hospital
Paris, 75013
Ahmed IDBAIH, MD-PhD, 01 42 16 03 85 ext. +33, ahmed.idbaih@aphp.fr
About this study
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.
Read the detailed description
Glioblastoma (GBM) is the most common and most aggressive primary brain tumor in adults, with an annual incidence in France of approximately 2,500-3,500 new cases. Despite intensive multimodal treatment, the median overall survival remains less than 18 months.
For reasons that are not yet fully understood, GBM occurs more frequently in men than in women, with a male-to-female ratio of approximately 1.6. Moreover, male sex appears to be associated with a poorer prognosis, as men diagnosed with GBM tend to have shorter survival compared with women. Importantly, such sex-based differences are not restricted to GBM; with few exceptions, they are also observed in most non-hormone-dependent systemic cancers.
These epidemiological and clinical observations suggest that sex and/or sex steroid hormones-particularly androgens-may contribute to GBM biology. The effects of androgens are primarily mediated through their binding to the androgen receptor (AR). Preliminary data indicate that AR is expressed not only by GBM tumor cells but also by cells within the tumor microenvironment, especially cells of the myeloid lineage, including microglia and tumor-associated macrophages.
In addition, some studies have shown that certain GBM cells are capable of producing dihydrotestosterone. Taken together, these findings support a potential role for androgen signaling in modulating both tumor cells and the immune microenvironment in GBM. They also provide a rationale for evaluating anti-androgen therapies, either alone or in combination with other treatment modalities, including immunotherapies, in patients with GBM.
Further support for this hypothesis comes from studies in systemic cancers. In prostate cancer, for example, anti-androgen therapy has been shown to increase cytotoxic T lymphocyte infiltration. Combinations of hormone therapy and immunotherapy have been tested in preclinical models, demonstrating reduced androgen-induced immunosuppression and enhanced sensitivity to immune checkpoint inhibitors, an approach currently being explored in clinical trials. Moreover, in melanoma-a non-hormone-dependent cancer such as GBM-AR silencing increases cytotoxic T-cell infiltration, reduces regulatory T-cell infiltration, and decreases the expression of immune inhibitory molecules such as LAG-3 and PD-1.
- Conditions
- Glioblastoma (GBM)
- Being tested
- blood sampling, saliva sampling, stool sampling, Tumor sampling
- Keywords
- Glioblastoma, Androgen
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
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 samplingOther
During these same visits at T1 and T2, a saliva sample will be collected using Salivette® Cortisol saliva collection devices (UGAP ref.: 2745674)
stool samplingOther
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 samplingOther
At the time of surgery performed as part of treatment (before T1), tumor tissue from the surgical waste will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Glioblastoma patients | Experimental | Adult men and women with GBM who are being treated in the neuro-oncology department at La Pitié-Salpêtrière Hospital. Receives: Other: blood sampling; Other: saliva sampling; Other: stool sampling; Other: Tumor sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Percentage of immunosuppressive cells measured at T1 and T2 in the blood and tumor using spectral cytometry
Measured: Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy
Profile of immunosuppressive cytokines in the tumor
Profile of immunosuppressive cytokines in the tumor (quantification of a panel of cytokines)
Measured: Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy
Mean of the Proportion of intratumoral immune cells
Proportion of intratumoral immune cells via the deconvolution of tumor RNA sequencing data
Measured: Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed IDBAIH, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472387
- Sponsor's protocol ID
- APHP241106
- Acronym
- Andro-iGlio
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Androgen Signaling on the Composition of the Immune Microenvironment in Glioblastomas
- ClinicalTrials.gov ID
- NCT07472387
- Acronym / sponsor ID
- Andro-iGlio / APHP241106
- Conditions
- Glioblastoma (GBM)
- Keywords
- Glioblastoma, Androgen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Glioblastoma (GBM) is the most common and most aggressive primary brain tumor in adults, with an annual incidence in France of approximately 2,500-3,500 new cases. Despite intensive multimodal treatment, the median overall survival remains less than 18 months.
For reasons that are not yet fully understood, GBM occurs more frequently in men than in women, with a male-to-female ratio of approximately 1.6. Moreover, male sex appears to be associated with a poorer prognosis, as men diagnosed with GBM tend to have shorter survival compared with women. Importantly, such sex-based differences are not restricted to GBM; with few exceptions, they are also observed in most non-hormone-dependent systemic cancers.
These epidemiological and clinical observations suggest that sex and/or sex steroid hormones-particularly androgens-may contribute to GBM biology. The effects of androgens are primarily mediated through their binding to the androgen receptor (AR). Preliminary data indicate that AR is expressed not only by GBM tumor cells but also by cells within the tumor microenvironment, especially cells of the myeloid lineage, including microglia and tumor-associated macrophages.
In addition, some studies have shown that certain GBM cells are capable of producing dihydrotestosterone. Taken together, these findings support a potential role for androgen signaling in modulating both tumor cells and the immune microenvironment in GBM. They also provide a rationale for evaluating anti-androgen therapies, either alone or in combination with other treatment modalities, including immunotherapies, in patients with GBM.
Further support for this hypothesis comes from studies in systemic cancers. In prostate cancer, for example, anti-androgen therapy has been shown to increase cytotoxic T lymphocyte infiltration. Combinations of hormone therapy and immunotherapy have been tested in preclinical models, demonstrating reduced androgen-induced immunosuppression and enhanced sensitivity to immune checkpoint inhibitors, an approach currently being explored in clinical trials. Moreover, in melanoma-a non-hormone-dependent cancer such as GBM-AR silencing increases cytotoxic T-cell infiltration, reduces regulatory T-cell infiltration, and decreases the expression of immune inhibitory molecules such as LAG-3 and PD-1.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma patients | Experimental | Other: blood sampling, Other: saliva sampling, Other: stool sampling, Other: Tumor samplingAdult men and women with GBM who are being treated in the neuro-oncology department at La Pitié-Salpêtrière Hospital. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients aged ≥18 and ≤55
- Newly diagnosed GBM
- Surgery with complete or incomplete resection
- Eligible for chemoradiotherapy
- No active immune disorders
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingAdditional 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) | Other | Glioblastoma patients |
| saliva samplingDuring these same visits at T1 and T2, a saliva sample will be collected using Salivette® Cortisol saliva collection devices (UGAP ref.: 2745674) | Other | Glioblastoma patients |
| stool samplingDuring 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) | Other | Glioblastoma patients |
| Tumor samplingAt the time of surgery performed as part of treatment (before T1), tumor tissue from the surgical waste will be collected. | Other | Glioblastoma patients |
Primary outcome
Mean expression of AR, ER, and other hormone signaling pathway genes in the tumor
Time frame: 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
3 secondary outcomes
Mean of Percentage of immunosuppressive cells measured at T1 and T2 in the blood and tumor
Time frame: Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy
Profile of immunosuppressive cytokines in the tumor
Time frame: Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy
Mean of the Proportion of intratumoral immune cells
Time frame: Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed IDBAIH, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling, saliva sampling and stool sampling in people with Glioblastoma (GBM), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed IDBAIH, MD-PhD (01 42 16 03 85 ext. +33, ahmed.idbaih@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean expression of AR, ER, and other hormone signaling pathway genes in the tumor (time frame: Baseline: Before any treatment; 4 to 6 weeks after completion of the concurrent radiochemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.