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NCT04765410: EUS-FNA

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

Completed Results posted Last updated 16 April 2026
What this trial tests

trial testing EUS FNA (endoscopic ultrasound fine needle aspiration) in Pancreatic Adenocarcinoma in 57 participants. Completed in 1 March 2022.

Timeline
21 March 2019
Primary endpoint
1 September 2021
1 March 2022

Quick facts

Lead sponsorCarol Davila University of Medicine and Pharmacy
StatusCompleted
Study typeOBSERVATIONAL
Enrollment57
Start date21 March 2019
Primary completion1 September 2021
Estimated completion1 March 2022
Sites5 locations across Romania

Drugs / interventions tested

Conditions studied

Sponsor

Carol Davila University of Medicine and Pharmacy

Who can join

18 and older, any sex, with Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Survival in Patients With Pancreatic Adenocarcinoma According to Tissue microRNA Expression Primary · through study completion, an average of 2 and a half years

Survival will be assessed though different consultations (in person or by telemedicine). Patient follow-up was conducted over 2 years and 6 months, consisting of periodic telephone visits at 1 month, 3 months, 6 months, 1 year, 2 years, and 2½ years (until the end of the study), respectively, collecting the following data: history and ECOG score.

GroupValue95% CI
Patients With Solid Pancreatic Masses8.3± 7.526

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 and a half years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With Solid Pancreatic Masses
Serious: 37/41 (90%)
Deaths: 41/41

Serious adverse events (1 terms)

ReactionSystemPatients With Solid Pancre…
deathNeoplasms benign, malignant and unspecified (incl cysts and polyps)

Most-reported serious reactions: death.

Data from ClinicalTrials.gov NCT04765410 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Non-coding RNAs as therapeutic targets in cancer and its clinical application.
    Leng X, Zhang M, Xu Y, Wang J, et al · · 2024 · cited 20× · PMID 39149142 · DOI 10.1016/j.jpha.2024.02.001
  2. RNA modifications in cancer.
    Wu H, Chen S, Li X, Li Y, et al · · 2025 · cited 5× · PMID 39802639 · DOI 10.1002/mco2.70042
  3. Epigenetic reprogramming in pancreatic premalignancy and clinical implications.
    Zhang W, Jiang T, Xie K. · · 2023 · cited 2× · PMID 36874143 · DOI 10.3389/fonc.2023.1024151

Verify or expand the search:

Other recruiting trials for Pancreatic Adenocarcinoma

Currently open trials in the same condition.

Other Carol Davila University of Medicine and Pharmacy trials

Trials by the same sponsor.

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Data sources for this page

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