Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203496
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2024-01-03
Brief Title:
Monitoring of Patients With Diffuse Gliomas Using Circulating miRNAs
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Monitoring of Patients With Diffuse Gliomas Using Circulating miRNAs
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GliomiR
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 Morokoffs 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
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
Detailed Description:
Diffuse gliomas are the most common primary tumors of the central nervous system representing around 3400 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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None