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GliomaGLIOLIPSYNCT05133154

LIQUID BIOPSY IN Low-grade Glioma Patients

A study testing Blood samples in people with Glioma, run by University Hospital, Montpellier at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Diffuse low-grade gliomas (DLGG) (or WHO grade II gliomas) are rare tumors, with an incidence estimated at 1/105 person-year. DLGG are characterized by a continuous growth and an unavoidable anaplastic transformation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioma
What is being tested?
Blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
1 Jan 2022to 5 Jul 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient aged ≥ 18, no age limit
  • A signed informed consent obtained before any study specific procedures
  • Patient affiliated to a French social security system
  • Patient ability to understand experimental procedures
  • Patient able to speak, read and understand French
  • Also for the "Low-grade glioma" group, the following inclusion criteria applies:
Show all 11Show fewer
  • Brain surgery for a suspected low-grade tumor, histologically confirmed on tumor sample
  • Also for the "High-grade glioma" group, the following inclusion criteria applies:
  • Brain surgery for a suspected high-grade glioma, histologically confirmed on tumor sample
  • Also for the "Control group, the following inclusion criteria applies:
  • Brain surgery for a non-tumor disease (cavernoma, arteriovenous malformation)

Who cannot join

  • Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to terminate the study
  • Pregnant and/or breastfeeding women (this will be checked in declarative way)
  • Patients with medical history of cancer other than the brain tumor, whatever the treatment received
  • Also, for the "Low-grade glioma" group, the following exclusion criteria applies:
  • Previous chemotherapy or radiation therapy for the low-grade glioma (but previous surgery/ies is/are allowed)
  • No indication for chemotherapy for 6 month after surgery
Show all 10Show fewer
  • Also, for the "High-grade glioma" group, the following exclusion criteria applies:
  • Previous chemotherapy or radiation therapy for the glioma
  • Also, for the "control" group, the following exclusion criteria applies:
  • Diagnosis or suspicion of primary or secondary brain tumor

Trial locations and contacts

1 site in 1 country.

France1 site
  • University Hospital, Montpellier

    Montpellier

Other trials in France

About this study

Diffuse low-grade gliomas (DLGG) (or WHO grade II gliomas) are rare tumors, with an incidence estimated at 1/105 person-year. DLGG are characterized by a continuous growth and an unavoidable anaplastic transformation. DLGG malignant progression is classically characterized by a continuum, from grade II to grade III or IV tumors.

To date, the histomolecular diagnosis of lower grade gliomas (that is, grade II and III gliomas) is achieved on tumor samples obtained from surgical resection or biopsy. Indeed, whereas brain MRI is often suggestive of DLGG, there is a need for a histological confirmation of diagnosis prior to any medical treatment. Moreover, MRI features to not always accurately predict the tumor grade, with grade II tumor presenting with contrast enhancement or non-enhancing authentic grade III tumors.

Read more

In this setting, the value of liquid biopsy (in blood or cerebrospinal fluid CSF) as a non-invasive, disease-associated biomarker has gained interest in the past decade, either at tumor diagnosis or to monitor tumor evolution in order to guide patient management and to detect changes of molecular features over time. While extracranial metastasis of glioma rarely occurs, recent reports suggest the possible presence of circulating tumor cells (CTCs) in blood of high-grade glioma patients. Beside CTCs, other circulating biomarkers have been recently investigated in glioma, including circulating tumor DNA, microRNA or tumor-educated platelet (TEP) RNA. Some of these techniques allow genome-wide characterization of RNA/DNA contents.

However, these studies are all small exploratory studies that have mainly included glioblastoma (grade IV glioma) patients rather than lower-grade gliomas, or glioma patients with no precision on tumor grade. Moreover, some of these studies analyzed samples performed after the patient received a medical oncological treatment (chemotherapy or radiation therapy). They advocate for the search of a circulating signature that would not be restricted to biomarkers directly derived from the tumor but include markers induced at a distance by the tumor. Indeed, slow-growing DLGG are likely to induce a systemic reaction to allow, for many years, an immuno-tolerance of the tumor. This reaction could have an impact on peripheral blood cells, including their RNA content.

In this study, the investigators aim at conducting an exploratory study in DLGG patients to explore the value of several blood-based biomarkers for the disease diagnosis and/or monitoring.

Read the detailed description

This study is a prospective, exploratory and bi-centric study.

The primary objective is to evaluate the presence of CTCs in a preoperative sample for the 3 following groups : patients with low-grade glioma, patients with high-grade glioma and patients undergoing neurosurgery for a non-tumor disease.

Visits in this study are as follows :

Inclusion Visit (V0) : 2 days (+/- 2 days) before brain surgery

Postoperative visits :

  • Visit 1: 2 days (+/- 2 days) following brain surgery
  • Visit 2: 3 months (+/- 1 month) following brain surgery
Conditions
Glioma
Being tested
Blood samples
Keywords
Low-grade glioma, High-grade glioma, Circulating tumor cells, Circulating biomarker, Tumor-educated platelets
Medical subject headings
Glioma, Neoplastic Cells, Circulating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samplesBiological

    In total, about 20 ml of blood will be collected on EDTA tubes : collection of CTCs, TEPs and biobanking (V0, V1 and V2)

Study groups in NCT05133154
Study groupRoleWhat they receive
Patients with low-grade gliomaOtherGroup 1
Receives: Biological: Blood samples
Patients with high-grade gliomaOtherGroup 2
Receives: Biological: Blood samples
Patients undergoing brain surgery for a non-tumor diseaseOtherGroup 3
Receives: Biological: Blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with CTCs (>0) in a preoperative sample for the 3 following groups (patients with low-grade glioma, patients with high-grade glioma and patients undergoing neurosurgery for a non-tumor disease)

    Measured: 14 months

Secondary outcomes (19)
  1. Number and characteristics of CTCs (in patients with CTCs) in a preoperative sample for the 3 groups of patients

    Measured: Baseline

  2. Platelets RNA profile in a preoperative sample for the 3 groups

    Measured: Baseline

  3. Number, characteristics of CTCs (in patients with CTCs) and platelets profile in a postoperative sample for the 3 groups

    Measured: 2 days following brain surgery

  4. Number, characteristics of CTCs (in patients with CTCs) and platelets profile in a postoperative sample for the 3 groups

    Measured: 3 months following brain surgery

  5. FLAIR tumor volume

    calculated by manual segmentation of the tumor borders on preoperative T2/FLAIR weighted MRI

    Measured: Baseline

  6. Spontaneous growth speed

    calculated as the evolution in mm/year of the mean tumor diameter derived from tumor volume (mm/year)

    Measured: Baseline

  7. Contrast enhancement

    defined on post Gadolinium pre-operative MRI (presence or absence)

    Measured: Baseline

  8. Tumor location

    Measured: Baseline

  9. ECOG performance status

    Measured: Baseline + 3 months following brain surgery

  10. Tumor-associated symptoms

    Measured: Baseline + 3 months following brain surgery

  11. Time interval since the first symptoms and the first MRI

    Measured: Baseline

  12. Associated drugs (antiepileptic drugs, corticosteroids)

    Measured: Baseline + 3 months following brain surgery

  13. Previous treatments for the tumor

    Measured: Baseline + 3 months following brain surgery

  14. WHO classification

    Measured: 3 months following brain surgery

  15. IDH status

    Measured: 3 months following brain surgery

  16. 1p19q status

    Measured: 3 months following brain surgery

  17. ATRX status

    Measured: 3 months following brain surgery

  18. Proliferation index (Ki67)

    Measured: 3 months following brain surgery

  19. Presence of foci of malignant transformation

    Measured: 3 months following brain surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start1 Jan 2022
  3. Primary completion1 Dec 2022
  4. Study completion5 Jul 2026 (estimated)

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The subjects will be included in the 3 following groups : * Group 1 : "Low-grade glioma" group: n=30 * Group 2 : "High-grade glioma" group: n=10 * Group 3 : "Control" (patients undergoing brain surgery for a non-tumor disease) group: n=10
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05133154
Sponsor's protocol ID
RECHMPL20_0671
Other IDs
2021-A00584-37
Acronym
GLIOLIPSY
Status last verified
Jun 2026
First submitted
25 Oct 2021
Last updated
22 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood samples in people with Glioma, run by University Hospital, Montpellier 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 11 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with CTCs (>0) in a preoperative sample for the 3 following groups (patients with low-grade glioma, patients with high-grade glioma and patients undergoing neurosurgery for a non-tumor disease) (time frame: 14 months). 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 22 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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