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| Name | Class |
|---|---|
| Bucharest Emergency Hospital | OTHER |
| Institutul Clinic Fundeni | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with solid pancreatic masses | Patients with solid pancreatic masses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 2 and a half years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with solid pancreatic masses fulfilling the inclusion and exclusion criteria will receive EUS FNA (endoscopic ultrasound fine needle aspiration).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Carol Davila" University Central Emergency Hospital | Bucharest | Sector 1 | 010825 | Romania | ||
| "Prof Dr Agrippa Ionescu" Emergency Hospital |
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Bearing in mind that COVID pandemic limited acces to medical resources, the numer of patients enrolled is slightly lower than anticipated.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Mean survival within the group was, 8.3 months [1-30 months]. | Posted | Mean | Standard Deviation | months | through study completion, an average of 2 and a half years |
|
2 and a half years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Solid Pancreatic Masses | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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Further studies performed on larger groups of patients to strengthen the value of the data obtained. Follow-up of patients in the comparative chronic pancreatitis group was essential to strengthen the diagnosis. Another limitation of the study is the lack of histopathological analysis of samples directed to miRNA examination, for this problem we performed qualitative analysis of the tissue submitted and subsequently by bioinformatics programs and statistical analysis we have identified ouliers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Mihai Ciocirlan | Carol Davila University of Medicine and Pharmacy | +40751015445 | drcatalinavladut@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 14, 2026 | Apr 14, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D061765 | Endoscopic Ultrasound-Guided Fine Needle Aspiration |
| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
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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.
| Bucharest |
| Sector 1 |
| 011356 |
| Romania |
| Clinical Emergency Hospital Bucharest | Bucharest | Sector 1 | 014461 | Romania |
| Fundeni Clinical Institute | Bucharest | Sector 2 | 022328 | Romania |
| "Victor Babes" National Pathology Institute | Bucharest | Sector | 050096 | Romania |
| 5 patients diagnosed with chronic pancreatitis; 1 patient with primary pancreatic lymphoma |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 41 |
| 41 |
| 37 |
| 41 |
| 0 |
| 41 |
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| D003584 |
| Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061705 | Image-Guided Biopsy |
| D013048 | Specimen Handling |
| D018084 | Ultrasonography, Interventional |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |