Pancreatic AdenocarcinomaEUS-FNANCT04765410
The Impact Of Tissue Micro-RNA Profile From EUS-FNA In Pancreatic Adenocarcinoma
An observational study of Pancreatic Adenocarcinoma, run by Carol Davila University of Medicine and Pharmacy at 5 sites in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- EUS FNA (endoscopic ultrasound fine needle aspiration)
- How many people
- 57 participants
- Where
- 5 sitesRomania
- Study dates
- 21 Mar 2019to 1 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with solid pancreatic masses fulfilling the inclusion and exclusion criteria will receive EUS FNA (endoscopic ultrasound fine needle aspiration).
Who may be able to join
- Pancreatic solid mass, with or without a cystic component
- Age over 18 years old
- Signed informed consent
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Romania5 sites
"Carol Davila" University Central Emergency Hospital
Bucharest, Sector 1, 010825
"Prof Dr Agrippa Ionescu" Emergency Hospital
Bucharest, Sector 1, 011356
Clinical Emergency Hospital Bucharest
Bucharest, Sector 1, 014461
Fundeni Clinical Institute
Bucharest, Sector 2, 022328
"Victor Babes" National Pathology Institute
Bucharest, Sector, 050096
About this study
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
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.
Read more
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
- Being tested
- EUS FNA (endoscopic ultrasound fine needle aspiration)
- Keywords
- microRNA, endoscopic ultrasonography, fine needle aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients with solid pancreatic masses | Patients with solid pancreatic masses Receives: Diagnostic Test: EUS FNA (endoscopic ultrasound fine needle aspiration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start21 Mar 2019
- Primary completion1 Sep 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Bucharest Emergency Hospital, Institutul Clinic Fundeni
- Responsible party
- Principal investigator, Mihai Ciocirlan, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765410
- Sponsor's protocol ID
- PDACmiRNA
- Acronym
- EUS-FNA
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2021
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04765410
- Acronym / sponsor ID
- EUS-FNA / PDACmiRNA
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- microRNA, endoscopic ultrasonography, fine needle aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Bucharest Emergency Hospital, Institutul Clinic Fundeni
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 16 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with solid pancreatic masses | – | Diagnostic Test: EUS FNA (endoscopic ultrasound fine needle aspiration)Patients with solid pancreatic masses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid pancreatic masses fulfilling the inclusion and exclusion criteria will receive EUS FNA (endoscopic ultrasound fine needle aspiration).
Key inclusion criteria (3 listed)
- Pancreatic solid mass, with or without a cystic component
- Age over 18 years old
- Signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Diagnostic test | Patients with solid pancreatic masses |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Adenocarcinoma, run by Carol Davila University of Medicine and Pharmacy at 5 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival in Patients With Pancreatic Adenocarcinoma According to Tissue microRNA Expression (time frame: through study completion, an average of 2 and a half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.