Trial Outcomes & Findings for The Impact Of Tissue Micro-RNA Profile From EUS-FNA In Pancreatic Adenocarcinoma (NCT NCT04765410)
NCT ID: NCT04765410
Last Updated: 2026-04-16
Results Overview
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.
COMPLETED
57 participants
through study completion, an average of 2 and a half years
2026-04-16
Participant Flow
Bearing in mind that COVID pandemic limited acces to medical resources, the numer of patients enrolled is slightly lower than anticipated.
Participant milestones
| Measure |
Patients With Solid Pancreatic Masses
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).
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Patients With Solid Pancreatic Masses
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).
|
|---|---|
|
Overall Study
biopsy sample was not sufficient to perform miRNA processing
|
2
|
|
Overall Study
"outlier detection"
|
2
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
5 patients diagnosed with chronic pancreatitis; 1 patient with primary pancreatic lymphoma
|
6
|
Baseline Characteristics
The Impact Of Tissue Micro-RNA Profile From EUS-FNA In Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Patients With Solid Pancreatic Masses
n=41 Participants
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).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=193 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=193 Participants
|
|
Age, Continuous
|
66.21 years
STANDARD_DEVIATION 10.12 • n=193 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Region of Enrollment
Romania
|
41 participants
n=193 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 2 and a half yearsPopulation: Mean survival within the group was, 8.3 months \[1-30 months\].
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.
Outcome measures
| Measure |
Patients With Solid Pancreatic Masses
n=41 Participants
Patients with solid pancreatic masses
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).
|
|---|---|
|
Survival in Patients With Pancreatic Adenocarcinoma According to Tissue microRNA Expression
|
8.3 months
Standard Deviation 7.526
|
Adverse Events
Patients With Solid Pancreatic Masses
Serious adverse events
| Measure |
Patients With Solid Pancreatic Masses
n=41 participants at risk
Patients with solid pancreatic masses
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).
The study protocol aimed at enrolling and evaluating the 57 patients in the study and performing the history and objective examination. Of the 57 patients enrolled in the study: 45 were confirmed with PDAC at histopathology examination, 5 patients were diagnosed with chronic pancreatitis (this being the comparative group in the second study); 1 patient was diagnosed with primary pancreatic lymphoma, 6 patients were not confirmed with PDAC at histopathology analysis. Of the 45 patients confirmed with PDAC, 2 patients were excluded as the biopsy sample was not sufficient to perform miRNA processing. This left 43 patients from which 2 patients were excluded after PCA analysis from SPSS statistical processing software "outlier detection", leaving the study group with 41 patients.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
death
|
90.2%
37/41 • 2 and a half years
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Mihai Ciocirlan
Carol Davila University of Medicine and Pharmacy
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place