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Monitoring of Patients With Diffuse Gliomas Using Circulating miRNAs

Study Purpose

MicroRNAs are small non-coding RNAs involved in the post-transcriptional regulation of genes and, consequently, of intracellular signalling pathways that govern cellular behaviour (Komatsu et al., 2023). They are widely implicated in oncogenesis, and in particular in mechanisms promoting cell migration, invasion and proliferation (Romano et al., 2021). Several preliminary studies have shown that serum levels of pro-oncogenic microRNAs correlate with tumor rates in gliomas (Jones et al., 2021; Levallet et al., 2022; Morokoff et al., 2020). Morokoff's study showed encouraging but insufficient results on the possibility of using microRNAs to differentiate radionecrosis versus recurrence. These results need to be consolidated prospectively, with homogeneous samples taken from all patients. The aim of this study is to describe the evolution over time of plasma levels of pro-oncogenic microRNAs, after surgery for grade 4 glioma, in order to assess whether they can be used to identify false-positive recurrences on MRI (radionecrosis).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Major patient.
  • - Grade 4 diffuse glioma.
  • - Surgery in the neurosurgery department of Caen University Hospital.
  • - Patient affiliated to a social security scheme.
  • - Patient followed at Caen University Hospital.
  • - No opposition from patient.

Exclusion Criteria:

  • - - Patients who underwent biopsy (lack of material for study, limited interest of monitoring for these patients without surgical excision).
  • - Patients with grade 1 circumscribed glioma or grade 2 or 3 diffuse glioma.
  • - Other non-glial histologies, glioneuronal histology.
  • - Minor patients.
  • - Patient not affiliated to a social security scheme.
  • - A minor under guardianship or protection.
- Patient opposed to study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06203496
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University Hospital, Caen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma, Malignant
Additional Details

Diffuse gliomas are the most common primary tumors of the central nervous system, representing around 3,400 cases per year in France (Defossez et al., 2019). Their grade varies from 2 to 4. Whatever the grade, their prognosis is dismal (Grade 2: median survival > 10 years, Grade 3: median survival around 5 years, Grades 4: median survival < 2 years) (Yang et al., 2016). Grade 4 diffuse gliomas are the most common gliomas. Their treatment is based on excision of the tumor as completely as possible while preserving the patient's neurological functions. This surgical treatment is followed by a "Stupp" radiochemotherapy protocol (Stupp et al., 2005). Nevertheless, recurrence of grade 4 gliomas after surgery is inevitable, and usually occurs within 2 years of surgery (Pineda et al., 2023). In fact, gliomas are infiltrating tumors, with tumor cells infiltrating the brain parenchyma up to 2 cm from the periphery of the tumor visualized on MRI, which explains their inevitable recurrence, since surgery cannot be wide (it is difficult to achieve "safety margins" at the cerebral level) and will invariably leave tumor cells in situ (Pallud et al., 2013). In the event of recurrence, second-line chemotherapy or further surgery may then be proposed to the patient. Patients are monitored by regular brain MRI scans, but it is important to be aware of the risks involved.

Contact a Trial Team

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International Sites

Arthur Leclerc, Caen, France

Status

Recruiting

Address

Arthur Leclerc

Caen, , 14000

Site Contact

Arthur Leclerc, MD, MSc

[email protected]

+33231064601

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