Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539431
Status:
UNKNOWN
Last Update Posted:
2022-01-24
First Post:
2020-08-31
Brief Title:
Glioma Brain Tumours - E12513 - SensiScreen Glioma
Sponsor:
Ente Ospedaliero Cantonale Bellinzona
Organization:
Ente Ospedaliero Cantonale Bellinzona
Study Overview
Official Title:
Sensitive Diagnosis Prognosis and Treatment Planning on Open Platform of Glioma Brain Tumours - E12513 - SensiScreen Glioma
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Validation of a new platform for the molecular characterization of patients affected by glioma The new platform includes a series of faster less expensive real-time PCR methodologies that in comparison to standard analyses DS MS-PCR are also characterized by higher sensitivity and consequently can be able to identify mutations in ctDNA extracted from liquid biopsies as well The development of these assays will allow the analysis of molecular markers alteration even in liquid biopsies providing a less invasive sampling than tissue biopsies a procedure that sometimes is characterized by side effects or that allow the collection of few tissues for the histological and molecular diagnosis
This study will not interfere with the patients routine treatment pathway and there will be no deviation from the standard of care the molecular characterization of the tissues will be performed according to the standard diagnostic routine using the currently approved methodologies For the retrospective study it will be used the left-over DNA For the cohort that includes the collection and the subsequent analysis of liquid biopsies prospective study blood and CSF will be sampled during surgery
The mutations in the molecular markers will be analyzed in tissue as well as in plasma and CFS samples by the new real-time based assays Then the qualitative and quantitative values obtained on liquid biopsies with the new methodology will be compared to the results of the standard methodologies already obtained for diagnostic routine on surgical tissue samples of the same patients
This study will not interfere with the patients routine treatment pathway and there will be no deviation from the standard of care the molecular characterization of the tissues will be performed according to the standard diagnostic routine using the currently approved methodologies For the retrospective study it will be used the left-over DNA For the cohort that includes the collection and the subsequent analysis of liquid biopsies prospective study blood and CSF will be sampled during surgery
The mutations in the molecular markers will be analyzed in tissue as well as in plasma and CFS samples by the new real-time based assays Then the qualitative and quantitative values obtained on liquid biopsies with the new methodology will be compared to the results of the standard methodologies already obtained for diagnostic routine on surgical tissue samples of the same patients
Detailed Description:
None
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