Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04765410
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2021-02-18
Brief Title:
The Impact Of Tissue Micro-RNA Profile From EUS-FNA In Pancreatic Adenocarcinoma
Sponsor:
Carol Davila University of Medicine and Pharmacy
Organization:
Carol Davila University of Medicine and Pharmacy
Study Overview
Official Title:
Tissue Micro-RNA Profile Collected Through Endoscopic Ultrasonography Fine-Needle-Aspiration EUS-FNA In Pancreatic Adenocarcinoma And Its Impact On Survival And Prognosis
Status:
UNKNOWN
Status Verified Date:
2021-02
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:
EUS-FNA
Brief Summary:
Pancreatic adenocarcinoma still represents one of the hot-topics worldwide Endoscopic ultrasonography was a breakthrough bringing us closer to personalized treatment by getting histopathological samples through fine-needle-aspiration or fine-needle-biopsy These samples can be analyzed and offer the possibility to detect a micro-RNA profile
Micro-RNAs are small non-coding RNA molecules that interfere in genic expression Many studies focused on seric microRNA profile though there are many implications in tissue micro-RNA profile thus overexpression or under expression of these molecules might help us not only understand different cellular processes but also interfere in personalized medicine in the future
The investigators propose a prospective multicenter randomized cohort study on 60 patients with solid pancreatic masses to evaluate tissue microRNA profile obtained by EUS-FNA
The primary hypothesis is to correlate the microRNA tissular expression in pancreatic adenocarcinoma with tumor aggressive behavior survival and response to treatment
The samples will be obtained from the participants during endoscopic ultrasonography through fine needle aspiration after consent was given to be a part of the study prior to the intervention The probe will be preserved in a special recipient that stabilizes RNA and inhibits RNA-lazes thus preventing RNA degradation by endogenous ribonucleases
The analysis of miRNA profile will be made using qRT-PCR array method by miScript II RT Kit miScript SYBR Green PCR Kit și miScript miRNA PCR Array Human Cancer Pathway Finder MIHS-102Z Qiagen GmbH Thus a kit containing a number of 84 miRNAs will be analysed in every participant
Micro-RNAs are small non-coding RNA molecules that interfere in genic expression Many studies focused on seric microRNA profile though there are many implications in tissue micro-RNA profile thus overexpression or under expression of these molecules might help us not only understand different cellular processes but also interfere in personalized medicine in the future
The investigators propose a prospective multicenter randomized cohort study on 60 patients with solid pancreatic masses to evaluate tissue microRNA profile obtained by EUS-FNA
The primary hypothesis is to correlate the microRNA tissular expression in pancreatic adenocarcinoma with tumor aggressive behavior survival and response to treatment
The samples will be obtained from the participants during endoscopic ultrasonography through fine needle aspiration after consent was given to be a part of the study prior to the intervention The probe will be preserved in a special recipient that stabilizes RNA and inhibits RNA-lazes thus preventing RNA degradation by endogenous ribonucleases
The analysis of miRNA profile will be made using qRT-PCR array method by miScript II RT Kit miScript SYBR Green PCR Kit și miScript miRNA PCR Array Human Cancer Pathway Finder MIHS-102Z Qiagen GmbH Thus a kit containing a number of 84 miRNAs will be analysed in every participant
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