Monitoring of Patients With Low-grade Gliomas Using Circulating miRNA

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen

About this trial

With around 3,400 cases per year in France, diffuse gliomas are the most common primary tumours of the central nervous system. Their grade varies from 2 to 4. Whatever the grade, their prognosis is poor, because tumour recurrence is systematic, because no personalised medicine is available for the treatment of these cancers, and because the tools for monitoring recurrence are imperfect. Treatment of diffuse gliomas is based on removal of as much of the tumour as possible, whatever its grade. Surgery is followed by radiotherapy and chemotherapy depending on the grade and quality of the excision. In the event of recurrence, the patient may be offered second-line chemotherapy or further surgery. During and after treatment, patients are regularly monitored by MRI in order to detect any recurrence as early as possible and propose a new treatment. However, for grade 2 and 3 gliomas, MRI monitoring is imperfect because it cannot detect tumour recurrence at an early stage. Initiation of new treatment at the time of recurrence, which is inevitable, is therefore often delayed, which is harmful for patients.

It is therefore vital to identify a reliable, easy-to-use and non-invasive biomarker that can be used to monitor patients undergoing surgery for grade 2 and 3 diffuse gliomas, and thus enable earlier diagnosis of recurrence. These biomarkers could be microRNAs.

MicroRNAs are small non-coding RNAs involved in the regulation of genes and, consequently, of the intracellular signalling pathways that govern cell behaviour. They are therefore widely implicated in oncogenesis, and in particular in the mechanisms that promote tumour migration, invasion and proliferation.

Several preliminary studies have shown that serum levels of pro-oncogenic microRNAs correlate with tumour rates in gliomas. No study has investigated the possibility of using them to detect tumour recurrence earlier in grade 2 and 3 gliomas.

With this study, the investigators hope to use pro-oncogenic microRNAs to monitor glioma patients and diagnose early recurrence in grade 2 and 3 gliomas.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Major patient

Suffered from a grade 2-3 diffuse glioma

Surgery in the neurosurgery department of Caen University Hospital

Patient affiliated to a social security scheme

Disqualifiers

Patients who have undergone biopsy (lack of material for the study, limited value of monitoring for these patients without surgical excision)

Patients with grade 1 circumscribed glioma

Patients with grade 4 glioma

Other non-glial histologies, glioneuronal histology

Trial population

Major patient suffered from a grade 2-3 diffuse glioma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample

    Diagnostic test

    Blood sample and centrifugation

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Plasma levels of each microRNA at each time point

Plasma levels of each microRNA at each time point

Time frame
Day 0, Day 4, then every 6 months for 5 years

Secondary outcomes

1

Tumor volume

Tumor volume (cm3)

Time frame
Day 0, Day 4, then every 6 months for 5 years
2

Overall Survival

OS

Time frame
60 months
3

Progression free survival

PFS

Time frame
60 months

Other outcomes

Sponsors and contacts

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

University Hospital, Caen

Lead sponsor

Région Normandie

Collaborator