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

NCT04765410 | Completed Results

• 1 other identifier: PDACmiRNA
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Pancreatic Adenocarcinoma

Keywords

microRNA; endoscopic ultrasonography; fine needle aspiration

Outcome Measures

Primary Outcomes (1)

• Survival in Patients With Pancreatic Adenocarcinoma According to Tissue microRNA Expression

  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

Study Arms (1)

Patients with solid pancreatic masses

Patients with solid pancreatic masses

Diagnostic Test: EUS FNA (endoscopic ultrasound fine needle aspiration)

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).

Patients with solid pancreatic masses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead
• Bucharest Emergency Hospital: collaborator
• Institutul Clinic Fundeni: collaborator

Study Sites (5)

"Carol Davila" University Central Emergency Hospital

Bucharest, Sector 1, 010825, Romania

Location

"Prof Dr Agrippa Ionescu" Emergency Hospital

Bucharest, Sector 1, 011356, Romania

Location

Clinical Emergency Hospital Bucharest

Bucharest, Sector 1, 014461, Romania

Location

Fundeni Clinical Institute

Bucharest, Sector 2, 022328, Romania

Location

"Victor Babes" National Pathology Institute

Bucharest, Sector, 050096, Romania

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Limitations and Caveats

Further studies performed on larger groups of patients to strengthen the value of the data obtained. Follow-up of patients in the comparative chronic pancreatitis group was essential to strengthen the diagnosis. Another limitation of the study is the lack of histopathological analysis of samples directed to miRNA examination, for this problem we performed qualitative analysis of the tissue submitted and subsequently by bioinformatics programs and statistical analysis we have identified ouliers.

Results Point of Contact

• Title: Dr Mihai Ciocirlan
• Organization: Carol Davila University of Medicine and Pharmacy

drcatalinavladut@gmail.com

+40751015445

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Gastroenterology Department, Associate Professor (Clinical Professor)

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: March 21, 2019
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2026-04

Locations

RO (5)