Health TrialsbyHealthPanel

Pancreatic Cancer Screening in a Population at High Risk

ConditionsPancreatic Ductal AdenocarcinomaHereditary DiseasesPancreatitis, Chronic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasaryk Memorial Cancer Institute

About this trial

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".

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

willing to participate in the study

age 18+

chronic pancreatic disease in the context of cystic fibrosis or chronic pancreatitis

age 50+

Disqualifiers

Inability to undergo radical curative surgery for a pancreatic tumor.

Inability to undergo scheduled imaging examinations.

Incurable malignant cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • endoscopic ultrasonography

    Procedure/Surgery

    endoscopic ultrasonography - frequency defined by arm

  • magnetic resonance

    Procedure/Surgery

    magnetic resonance - frequency defined by arm

  • laboratory examination

    Diagnostic test

    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

Treatment groups

700 Participants
are divided into 4 treatment groups
Group A: A - chronic pancreatitisExperimental treatment 3 interventions
Group B: B1 - genetic predisposition (STK11, CDKN2A, PRSS1)Experimental treatment 3 interventions
Group C: B2 - genetic predisposition of hereditary syndromesExperimental treatment 3 interventions
Group D: C - positive family anamnesisExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Methods yield comparison

Comparison of magnetic resonance versus endoscopic ultrasonography yield

Time frame
through study completion, an average of 1 year
2

Screening methods cost-effectiveness

Comparison of magnetic resonance versus endoscopic ultrasonography cost effectiveness

Time frame
through study completion, an average of 1 year
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masaryk Memorial Cancer Institute

Lead sponsor

Masaryk University

Collaborator

Source ClinicalTrials.gov
Apply now