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

April 14, 2026 updated by: Mihai Ciocirlan, Carol Davila University of Medicine and Pharmacy

Tissue Micro-RNA Profile Collected Through Endoscopic Ultrasonography Fine-Needle-Aspiration (EUS-FNA) In Pancreatic Adenocarcinoma And Its Impact On Survival And Prognosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Sector
      • Bucharest, Sector, Romania, 050096
        • "Victor Babes" National Pathology Institute
    • Sector 1
      • Bucharest, Sector 1, Romania, 010825
        • "Carol Davila" University Central Emergency Hospital
      • Bucharest, Sector 1, Romania, 011356
        • "Prof Dr Agrippa Ionescu" Emergency Hospital
      • Bucharest, Sector 1, Romania, 014461
        • Clinical Emergency Hospital Bucharest
    • Sector 2
      • Bucharest, Sector 2, Romania, 022328
        • Fundeni Clinical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Pancreatic solid mass, with or without a cystic component
  • Age over 18 years old
  • Signed informed consent

Exclusion Criteria:

  • Cystic pancreatic mass with no solid component
  • Abnormal coagulation (elevated INR >1.5, thrombocytopenia<60 000/mm3, activated partial thromboplastin time>42 seconds), participant on anticoagulant treatment that cannot stop the treatment
  • European Cooperative Oncology Group status 4
  • Pregnancy
  • Age under 18 years old
  • The participant does not want to sign the consent form, or is unable to
  • Difficult puncture position during endoscopic ultrasonography: vessels or Wirsung duct positioned in front of the needle (decision of the endoscopist)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with solid pancreatic masses
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carol Davila University of Medicine and Pharmacy

Collaborators

Institutul Clinic Fundeni
Bucharest Emergency Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2019

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDACmiRNA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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