Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964153
Status:
RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-04-04
Brief Title:
Analysis of Circulating DNA in Blood Samples of Glioma-affected Patients
Sponsor:
Corporacion Parc Tauli
Organization:
Corporacion Parc Tauli
Study Overview
Official Title:
Pilot Study of Liquid Biopsy as a Diagnostic Tool for Gliomas by Analyzing Circulating Tumor DNA in Blood Samples and Its Validation With the Corresponding Tissue Biopsies
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
The present pilot study aims to investigate a new strategy in the liquid biopsy protocol for the diagnosis of gliomas based on the detection of circulating tumor DNA in the blood of patients with brain lesions compatible with this type of tumor
In order to increase the sensitivity of the technique the investigators will work with raw blood samples through minimally invasive procedures The subsequent analysis will be done with digital PCR due to its low detection limit The mutational results of each patients samples will be compared with those obtained from the corresponding tissue biopsies This step will allow the team to determine the robustness and reliability of the liquid biopsy The grading of the tumor as well as the confirmation of the diagnosis will be obtained from the histological data
With the inclusion of more patients in the future and with the optimization of the mutations investigated the investigators want to standardize the protocol for the diagnosis of gliomas with liquid biopsy This technique is less invasive than current surgical procedures used for diagnosis In addition using fewer hospital resources should allow a more accurate and rapid diagnosis of the pathology and therefore start the more personalized therapeutic stage earlier
In order to increase the sensitivity of the technique the investigators will work with raw blood samples through minimally invasive procedures The subsequent analysis will be done with digital PCR due to its low detection limit The mutational results of each patients samples will be compared with those obtained from the corresponding tissue biopsies This step will allow the team to determine the robustness and reliability of the liquid biopsy The grading of the tumor as well as the confirmation of the diagnosis will be obtained from the histological data
With the inclusion of more patients in the future and with the optimization of the mutations investigated the investigators want to standardize the protocol for the diagnosis of gliomas with liquid biopsy This technique is less invasive than current surgical procedures used for diagnosis In addition using fewer hospital resources should allow a more accurate and rapid diagnosis of the pathology and therefore start the more personalized therapeutic stage earlier
Detailed Description:
Currently brain tumors are detected by means of an imaging technique usually magnetic resonance imaging with a contrast agent The determination of the type of tumor as well as its grading is usually done subsequently with a biopsy of the tissue where different solid samples are extracted as representative as possible to analyze them in the Pathological Anatomy service Nevertheless there are some factors that limit surgical access such as the advanced age of the patient the location of the tumor in eloquent or risky areas as well as the presence of large tumors with very diffuse borders In these cases the diagnosis of the brain tumor is usually made directly with the magnetic resonance image which implies a risk of error due to the lack of clinical information from this test
Limitations like these make the minimally invasive procedure of liquid biopsy an extremely necessary diagnostic tool For this reason the investigators want to start a pilot study of this technique in those patients with brain lesions in the resonance images compatible with a glioma-like tumor
In particular the main aim of the study is to analyze the blood samples obtained from these patients in order to detect and quantify the circulating DNA ctDNA of tumor cells on it These DNA fragments are expelled into the bloodstream by mechanisms still unknown as a result of numerous processes of apoptosis and necrosis of tumor cells By analyzing them through a ddPCR the investigators will try to detect the specific mutations present in this tumoral ctDNA allowing the team to confirm the presence of a glioma-type tumor and providing real-time information of its classification as astrocytoma or oligodendroglioma
Limitations like these make the minimally invasive procedure of liquid biopsy an extremely necessary diagnostic tool For this reason the investigators want to start a pilot study of this technique in those patients with brain lesions in the resonance images compatible with a glioma-like tumor
In particular the main aim of the study is to analyze the blood samples obtained from these patients in order to detect and quantify the circulating DNA ctDNA of tumor cells on it These DNA fragments are expelled into the bloodstream by mechanisms still unknown as a result of numerous processes of apoptosis and necrosis of tumor cells By analyzing them through a ddPCR the investigators will try to detect the specific mutations present in this tumoral ctDNA allowing the team to confirm the presence of a glioma-type tumor and providing real-time information of its classification as astrocytoma or oligodendroglioma
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