Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05133154

LIQUID BIOPSY IN Low-grade Glioma Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Glioma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Cells, Circulating Neoplastic Processes Neuroectodermal Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Montpellier

Montpellier, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

  • 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)

Exclusion criteria

  • 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

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

Treatment and study plan

blood samples

Biological

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

Primary outcomes

  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)

    Time frame: 14 months

Secondary outcomes

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

    Time frame: Baseline

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

    Time frame: Baseline

  3. 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

  4. 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

  5. FLAIR tumor volume

    Time frame: Baseline

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

  6. Spontaneous growth speed

    Time frame: Baseline

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

  7. Contrast enhancement

    Time frame: Baseline

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

  8. Tumor location

    Time frame: Baseline

  9. ECOG performance status

    Time frame: Baseline + 3 months following brain surgery

  10. Tumor-associated symptoms

    Time frame: Baseline + 3 months following brain surgery

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

    Time frame: Baseline

  12. Associated drugs (antiepileptic drugs, corticosteroids)

    Time frame: Baseline + 3 months following brain surgery

  13. Previous treatments for the tumor

    Time frame: Baseline + 3 months following brain surgery

  14. WHO classification

    Time frame: 3 months following brain surgery

  15. IDH status

    Time frame: 3 months following brain surgery

  16. 1p19q status

    Time frame: 3 months following brain surgery

  17. ATRX status

    Time frame: 3 months following brain surgery

  18. Proliferation index (Ki67)

    Time frame: 3 months following brain surgery

  19. Presence of foci of malignant transformation

    Time frame: 3 months following brain surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: GLIOLIPSY

Important dates

Study start
2022
Primary completion
2022
Study completion
2026
First posted
Nov 24, 2021
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.