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

Pancreatic Adenocarcinoma Clinical Trial

— EUS-FNA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04765410
• Other study ID #: PDACmiRNA
• Status: Recruiting
• Start date: March 21, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2021
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: Catalina Vladut, MD
• Phone: +40751015445
• Email: drcatalinavladut[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

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).

Locations

Country	Name	City	State
Romania	"Carol Davila" University Central Emergency Hospital	Bucharest	Sector 1
Romania	"Prof Dr Agrippa Ionescu" Emergency Hospital	Bucharest	Sector 1
Romania	"Victor Babes" National Pathology Institute	Bucharest	Sector
Romania	Clinical Emergency Hospital Bucharest	Bucharest	Sector 1
Romania	Fundeni Clinical Institute	Bucharest	Sector 2

Sponsors (3)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy	Bucharest Emergency Hospital, Institutul Clinic Fundeni

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Eastern Cooperative Oncology Group (ECOG) performance status, weight and survival will be assessed though different consultations (in person or by telemedicine): at first presentation, at 1 month, at 3 months, at 6 months and at one year.	through study completion, an average of 2 and a half years