Monitoring of Patients With Diffuse Gliomas Using Circulating miRNAs

NCT06203496 | Recruiting

• 1 other identifier: 2023-A01732-43
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Glioma, Malignant

Keywords

Glioblastoma; Glioma; Biomarker; Radionecrosis

Outcome Measures

Primary Outcomes (1)

• Recurrence of glioma on MRI

  Aspect of recurrence on MRI

  2 years

Secondary Outcomes (2)

• OS

  2 years

• PFS

  2 years

Interventions

Blood sample DIAGNOSTIC_TEST

Blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with surgically resected grade 4 glioma

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Caen: lead

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

• 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.

  PMID: 36672241 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

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tumor sample

MeSH Terms

Conditions

Glioma; Glioblastoma

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; Astrocytoma

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: January 3, 2024
• First Posted: January 12, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)