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COMPLETED
NCT04765410

The Impact Of Tissue Micro-RNA Profile From EUS-FNA In Pancreatic Adenocarcinoma

Sponsor: Carol Davila University of Medicine and Pharmacy

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

57

Start Date

2019-03-21

Completion Date

2022-03-01

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

EUS FNA (endoscopic ultrasound fine needle aspiration)

Patients with solid pancreatic masses fulfilling the inclusion and exclusion criteria will receive EUS FNA (endoscopic ultrasound fine needle aspiration).

Locations (5)

"Carol Davila" University Central Emergency Hospital

Bucharest, Sector 1, Romania

"Prof Dr Agrippa Ionescu" Emergency Hospital

Bucharest, Sector 1, Romania

Clinical Emergency Hospital Bucharest

Bucharest, Sector 1, Romania

Fundeni Clinical Institute

Bucharest, Sector 2, Romania

"Victor Babes" National Pathology Institute

Bucharest, Sector, Romania