Pancreatic Adenocarcinoma
Conditions
Keywords
microRNA, endoscopic ultrasonography, 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.
Interventions
DIAGNOSTIC_TESTEUS 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).
Sponsors
Carol Davila University of Medicine and Pharmacy
Bucharest Emergency Hospital
Institutul Clinic Fundeni
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival in Patients With Pancreatic Adenocarcinoma According to Tissue microRNA Expression | 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. |
Countries
Romania
Participant flow
Pre-assignment details
Bearing in mind that COVID pandemic limited acces to medical resources, the numer of patients enrolled is slightly lower than anticipated.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 66.21 years STANDARD_DEVIATION 10.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Romania | 41 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 41 / 41 |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 37 / 41 |
Outcome results
None listed