An interventional study of endoscopic ultrasonography and magnetic resonance in Pancreatic Ductal Adenocarcinoma, Hereditary Diseases and Pancreatitis, Chronic, sponsored by Masaryk Memorial Cancer Institute. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Screening
Pancreatic cancer is one of the diseases with the worst prognosis, which is mainly due to the initial asymptomatic prognosis. Unfortunately, the incidence of this disease in the Czech Republic is still increasing. In a certain proportion of patients, it is possible to predict the disease, e.g. due to family burdens. Regular follow-up of such individuals is the subject of the SCREPAN study: "Pancreatic Cancer Screening in High-Risk Persons".
Pancreatic ductal adenocarcinoma (PDAC) is one of the cancers with the worst prognosis. Mortality in this disease is almost equal to the incidence. In the Czech Republic, the incidence of this cancer has an upward trend, in 2017, 21.2 new cases per 100,000 people were reported, which represents a more than double increase compared to the data from the 1970s.
Pancreatic cancer is associated with an extremely poor prognosis for several reasons. It is usually diagnosed at an advanced stage, which is often due to the asymptomatic course of the disease or non-specific symptoms, the lack of sensitive and specific tumor markers, and difficult diagnosis by imaging methods in the early stages. Five-year survival, regardless of clinical stage, is between 7-9%.
Resectable disease is diagnosed in only 10% of patients, in which the 5-year survival rate is 37 %, locally advanced unresectable disease is detected in about 30 % of patients with a 5-year survival of 12 %, and metastatic disease is found in about 60 % of patients, with a 5-year survival rate of only around 3 %.
The poor prognosis of this disease is also due to the limited possibilities of screening and curative intervention for a short "lead time" in rapidly metastatic disease.
Pancreatic cancer screening is not suitable for the non-selected population. On the contrary, it is important for individuals with a high risk of developing this disease. In these subjects, early diagnosis during screening demonstrated a higher number of curative resections and longer survival.
A:
B1:
B2:
C:
Exclusion Criteria:
Chronic pancreatitis, due to cystic fibrosis
Procedure: endoscopic ultrasonography · Procedure: magnetic resonance · Diagnostic Test: laboratory examination
Persons with a confirmed diagnosis of Peutz-Jeghers syndrome (STK11 mutation) or familial melanoma syndrome (CDKN2A mutation), hereditary pancreatitis (PRSS1 mutation)
Procedure: endoscopic ultrasonography · Procedure: magnetic resonance · Diagnostic Test: laboratory examination
Persons with a confirmed diagnosis of hereditary syndromes and at the same time with the condition of at least one relative of the first or second degree with a diagnosis of pancreatic ductal adenocarcinoma in family anamnesis; i.e. Lynch syndrome (mut: MLH1, MSH2, MSH6 a PMS2, EPCAM), HBOC (mut: BRCA1, BRCA2, PALB2, ATM), familial adenomatous polyposis (mut: APC), Li-Fraumeni syndrome (mut: TP53)
Procedure: endoscopic ultrasonography · Procedure: magnetic resonance · Diagnostic Test: laboratory examination
Persons with positive family anamnesis of pancreatic ductal adenocarcinoma without proven hereditary syndrome
Procedure: endoscopic ultrasonography · Procedure: magnetic resonance · Diagnostic Test: laboratory examination
endoscopic ultrasonography - frequency defined by arm
Also known as: EUS
magnetic resonance - frequency defined by arm
Also known as: MR
hematology, biochemistry, Na+, K+, Cl-, Ca2+, bilirubin, ALT, AST, GGT, ALP, lactate dehydrogenase, creatinine, urea, fasting glycemia, HbA1c, alpha-amylase, LPS, albumin, total protein, CA19-9, CEA
Also known as: LAB
Number of participants with newly diagnosed pancreatic ductal adenocarcinoma
Number of participants (in risk population) with newly diagnosed pancreatic cancer
Time frame: From date of subject enrollment annualy in determined examinations according to the protocol schedule until the date of PDAC diagnosis or up to 60 months of subject participation in the study
Methods yield comparison
Comparison of magnetic resonance versus endoscopic ultrasonography yield
Time frame: through study completion, an average of 1 year
Screening methods cost-effectiveness
Comparison of magnetic resonance versus endoscopic ultrasonography cost effectiveness
Time frame: through study completion, an average of 1 year
KRAS mutation status evaluation
KRAS mutation status defined by number of positive droplets on drop digital PCR using material from liquid biopsy
Time frame: From the date of subject enrollment annualy in determined examinations according to the protocol schedule until the date of PDAC diagnosis or up to 60 months of subject participation in the study
Plan to share: Undecided
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Masaryk Memorial Cancer Institute