The clinical significance of genetics factors research to refine the diagnosis, estimate prognosis and risk of recurrence after succesful pancreatic cancer resection.

The clinical significance of epigenetic factors research to refine the diagnosis, estimate prognosis and risk of recurrence after curative pancreatic cancer resection.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003248-36-CZ

Enrollment

120

Registered

2011-07-25

Start date

2011-09-30

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The aim of the study to estimate frequence of epigenetics changes in pancreatic cancer and to assess the signidicance of apllication of the intravenous contrast agent during endosonography to better visualusation of the lesions. MedDRA version: 14.0 Level: LLT Classification code 10016335 Term: Feeling hot and cold System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 14.0 Level: LLT Classification code 10037872 Term: Rash NOS System Organ Class: 1

Interventions

Trade Name: SonoVue Product Name: SonoVue Pharmaceutical Form: Powder and solvent for dispersion for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with chronic pancreatitis patients with pancreatic focal mass Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: age under 18 years pregnancy and lactation disagreement with participation in the study chronic pancreatitis without mass patients with severe heart and pulmonary failure

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective are concerned to epigenetics of pancreatic cancer not to contrast agent tested. Development of methodology for EUS-FNA suitable for carrying out routine sampling and pretreatment of pancreatic tissue samples providing sufficient quantity and quality of biological material for epigenetic testing and to assess sensitivity and specificity evaluation of epigenetic testing based on monitoring of selected methylation markers and miRNAs in the diagnosis of pancreatic lesions and to correlate DNA methylation specific markers and levels of specific miRNAs in pancreatic tissue with the clinical course of disease characterized by (i) the stage of disease, (ii) the response to cancer treatment, and (iii) survival. ;Secondary Objective: The secondary aim of the study is to evaluate the contribution of contrast enhanced endosonography (CEH-EUS) to refine the diagnosis of pancreatic disease. ;Primary end point(s): Sensitivity, specificity, positive predictive and negative predictive value of miRNA markers for pancreatic cancer diagnostics, prognosis of survival and for efficacy of therapy;Timepoint(s) of evaluation of this end point: 4 years	—

Measure

Time frame

Main Objective: Primary objective are concerned to epigenetics of pancreatic cancer not to contrast agent tested. Development of methodology for EUS-FNA suitable for carrying out routine sampling and pretreatment of pancreatic tissue samples providing sufficient quantity and quality of biological material for epigenetic testing and to assess sensitivity and specificity evaluation of epigenetic testing based on monitoring of selected methylation markers and miRNAs in the diagnosis of pancreatic lesions and to correlate DNA methylation specific markers and levels of specific miRNAs in pancreatic tissue with the clinical course of disease characterized by (i) the stage of disease, (ii) the response to cancer treatment, and (iii) survival. ;Secondary Objective: The secondary aim of the study is to evaluate the contribution of contrast enhanced endosonography (CEH-EUS) to refine the diagnosis of pancreatic disease. ;Primary end point(s): Sensitivity, specificity, positive predictive and negative predictive value of miRNA markers for pancreatic cancer diagnostics, prognosis of survival and for efficacy of therapy;Timepoint(s) of evaluation of this end point: 4 years

—

Secondary

Measure	Time frame
Secondary end point(s): Sensitivity and specificity, positive predictive value and negative predictive value of contrast enhanced endoscopic ultrasonography for pancreatic cancer;Timepoint(s) of evaluation of this end point: 4 years	—

Countries

Czech Republic

Contacts

Public ContactDepartment of Internal Medicine

Central Military Hospital

tereza.chvatalova@uvn.cz+420973 20 30 74

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026