Clinical trial NCT04765410: The Impact Of Tissue Micro-RNA Profile From EUS-FNA In Pancreatic Adenocarcinoma
Official title: Tissue Micro-RNA Profile Collected Through Endoscopic Ultrasonography Fine-Needle-Aspiration (EUS-FNA) In Pancreatic Adenocarcinoma And Its Impact On Survival And Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Adenocarcinoma
Keywords: microRNA
endoscopic ultrasonography
fine needle aspiration
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Bucharest Emergency Hospital
name: Institutul Clinic Fundeni
First posted: 2021-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Mean change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status, weight and survival in patients with pancreatic adenocarcinoma according to tissue microRNA expression
timeFrame: through study completion, an average of 2 and a half years
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Carol Davila" University Central Emergency Hospital
state: Sector 1
city: Bucharest
country: Romania
facility: "Prof Dr Agrippa Ionescu" Emergency Hospital
state: Sector 1
city: Bucharest
country: Romania
facility: Clinical Emergency Hospital Bucharest
state: Sector 1
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
state: Sector 2
city: Bucharest
country: Romania
facility: "Victor Babes" National Pathology Institute
state: Sector
Study officials:
References: