Monitoring of Patients With Diffuse Gliomas Using Circulating miRNAs

Glioma, Malignant Clinical Trial

— GliomiR  

Official title:

Monitoring of Patients With Diffuse Gliomas Using Circulating miRNAs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203496
• Other study ID #: 2023-A01732-43
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant

Intervention

Diagnostic Test:
• Blood sample
Blood sample

Locations

Country	Name	City	State
France	Arthur Leclerc	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (3)

Komatsu S, Kitai H, Suzuki HI. Network Regulation of microRNA Biogenesis and Target Interaction. Cells. 2023 Jan 13;12(2):306. doi: 10.3390/cells12020306. — View Citation

Levallet G, Dubois F, Leclerc A, Petit E, Bekaert L, Faisant M, Creveuil C, Emery E, Zalcman G, Lechapt-Zalcman E. The Use of Pro-Angiogenic and/or Pro-Hypoxic miRNAs as Tools to Monitor Patients with Diffuse Gliomas. Int J Mol Sci. 2022 May 27;23(11):6042. doi: 10.3390/ijms23116042. — View Citation

Morokoff A, Jones J, Nguyen H, Ma C, Lasocki A, Gaillard F, Bennett I, Luwor R, Stylli S, Paradiso L, Koldej R, Paldor I, Molania R, Speed TP, Webb A, Infusini G, Li J, Malpas C, Kalincik T, Drummond K, Siegal T, Kaye AH. Serum microRNA is a biomarker for post-operative monitoring in glioma. J Neurooncol. 2020 Sep;149(3):391-400. doi: 10.1007/s11060-020-03566-w. Epub 2020 Sep 11. Erratum In: J Neurooncol. 2020 Oct 7;: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of glioma on MRI	Aspect of recurrence on MRI	2 years
Secondary	OS	Overall Survival	2 years
Secondary	PFS	Progression free survival	2 years