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

Sponsor
Carol Davila University of Medicine and Pharmacy
Study ID
NCT04765410
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 21, 2019
Status verified
Apr 2026
Primary completion
Sep 1, 2021
Completion
Mar 1, 2022

Study Design

Enrollment
57 participants (actual)

Arms

  • Arm: Patients with solid pancreatic masses
    Patients with solid pancreatic masses

Primary Outcome Measure

Survival in Patients With Pancreatic Adenocarcinoma According to Tissue microRNA Expression [ Time Frame: through study completion, an average of 2 and a half years ]

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