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.
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.
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 group | Role | What they receive |
|---|---|---|
| Patients with low-grade glioma | Other | Group 1 Receives: Biological: Blood samples |
| Patients with high-grade glioma | Other | Group 2 Receives: Biological: Blood samples |
| Patients undergoing brain surgery for a non-tumor disease | Other | Group 3 Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Number and characteristics of CTCs (in patients with CTCs) in a preoperative sample for the 3 groups of patients
Measured: Baseline
Platelets RNA profile in a preoperative sample for the 3 groups
Measured: Baseline
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
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
FLAIR tumor volume
calculated by manual segmentation of the tumor borders on preoperative T2/FLAIR weighted MRI
Measured: Baseline
Spontaneous growth speed
calculated as the evolution in mm/year of the mean tumor diameter derived from tumor volume (mm/year)
Measured: Baseline
Contrast enhancement
defined on post Gadolinium pre-operative MRI (presence or absence)
Measured: Baseline
Tumor location
Measured: Baseline
ECOG performance status
Measured: Baseline + 3 months following brain surgery
Tumor-associated symptoms
Measured: Baseline + 3 months following brain surgery
Time interval since the first symptoms and the first MRI
Measured: Baseline
Associated drugs (antiepileptic drugs, corticosteroids)
Measured: Baseline + 3 months following brain surgery
Previous treatments for the tumor
Measured: Baseline + 3 months following brain surgery
WHO classification
Measured: 3 months following brain surgery
IDH status
Measured: 3 months following brain surgery
1p19q status
Measured: 3 months following brain surgery
ATRX status
Measured: 3 months following brain surgery
Proliferation index (Ki67)
Measured: 3 months following brain surgery
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.
- First posted24 Nov 2021
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion5 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine PANABIERES, MCU-PH, Ph.D., Study director, University Hospital, Montpellier
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIQUID BIOPSY IN Low-grade Glioma Patients
- ClinicalTrials.gov ID
- NCT05133154
- Acronym / sponsor ID
- GLIOLIPSY / RECHMPL20_0671
- Conditions
- Glioma
- Keywords
- Low-grade glioma, High-grade glioma, Circulating tumor cells, Circulating biomarker, Tumor-educated platelets
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 5 Jul 2026 (estimated)
- First posted
- 24 Nov 2021 (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.
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.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients with low-grade glioma | Other | Biological: Blood samplesGroup 1 |
| Patients with high-grade glioma | Other | Biological: Blood samplesGroup 2 |
| Patients undergoing brain surgery for a non-tumor disease | Other | Biological: Blood samplesGroup 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- 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
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 samplesIn total, about 20 ml of blood will be collected on EDTA tubes : collection of CTCs, TEPs and biobanking (V0, V1 and V2) | Biological | Patients undergoing brain surgery for a non-tumor disease, Patients with high-grade glioma, Patients with low-grade glioma |
Primary outcome
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
19 secondary outcomes
Number and characteristics of CTCs (in patients with CTCs) in a preoperative sample for the 3 groups of patients
Time frame: Baseline
Platelets RNA profile in a preoperative sample for the 3 groups
Time frame: Baseline
Number, characteristics of CTCs (in patients with CTCs) and platelets profile in a postoperative sample for the 3 groups
Time frame: 2 days following brain surgery
Number, characteristics of CTCs (in patients with CTCs) and platelets profile in a postoperative sample for the 3 groups
Time frame: 3 months following brain surgery
FLAIR tumor volume
Time frame: Baseline
Spontaneous growth speed
Time frame: Baseline
Contrast enhancement
Time frame: Baseline
Tumor location
Time frame: Baseline
ECOG performance status
Time frame: Baseline + 3 months following brain surgery
Tumor-associated symptoms
Time frame: Baseline + 3 months following brain surgery
Time interval since the first symptoms and the first MRI
Time frame: Baseline
Associated drugs (antiepileptic drugs, corticosteroids)
Time frame: Baseline + 3 months following brain surgery
Previous treatments for the tumor
Time frame: Baseline + 3 months following brain surgery
WHO classification
Time frame: 3 months following brain surgery
IDH status
Time frame: 3 months following brain surgery
1p19q status
Time frame: 3 months following brain surgery
ATRX status
Time frame: 3 months following brain surgery
Proliferation index (Ki67)
Time frame: 3 months following brain surgery
Presence of foci of malignant transformation
Time frame: 3 months following brain surgery
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 22 Jun 2026.
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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. This study is not recruiting at the moment.
Catherine PANABIERES, MCU-PH, Ph.D. study director
University Hospital, Montpellier
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 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.