Monitoring of Patients With Low-grade Gliomas Using Circulating miRNA

NCT06610851 | Recruiting

• 1 other identifier: 23-0162
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma; miRNA; Low-grade Glioma; Biomarkers

Keywords

glioma; miRNA; biomarker

Outcome Measures

Primary Outcomes (1)

• Plasma levels of each microRNA at each time point

  Plasma levels of each microRNA at each time point

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

Secondary Outcomes (3)

• Tumor volume

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

• Overall Survival

  60 months

• Progression free survival

  60 months

Interventions

Blood sample DIAGNOSTIC_TEST

Blood sample and centrifugation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major patient suffered from a grade 2-3 diffuse glioma

You may qualify if:

• 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
• Patient followed at Caen University Hospital
• No opposition from the patient

You may not qualify if:

• 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
• Minor patients
• Patient not affiliated to a social security scheme
• Major under guardianship or protected

Sponsors & Collaborators

• University Hospital, Caen: lead
• Région Normandie: collaborator

Study Sites (1)

Arthur LECLERC

Caen, 14000, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 35682718 BACKGROUND

• 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.

  PMID: 32915353 BACKGROUND

• Jones J, Nguyen H, Drummond K, Morokoff A. Circulating Biomarkers for Glioma: A Review. Neurosurgery. 2021 Feb 16;88(3):E221-E230. doi: 10.1093/neuros/nyaa540.

  PMID: 33442748 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample (plasma) and Tissu sample (FFPE)

MeSH Terms

Conditions

Glioma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: September 24, 2024
• Study Start: April 25, 2024
• Primary Completion: April 25, 2024
• Study Completion (Estimated): April 25, 2030
• Last Updated: September 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)