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NCT Number: NCT04765410

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Victor Babes" National Pathology Institute, Bucharest, Sector, Romania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Collaborators

  • Bucharest Emergency Hospital
  • Institutul Clinic Fundeni

Registry information

Official study title

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

Acronym: EUS-FNA

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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