RecruitingNot ApplicableNCT06330441

Pancreatic Cancer Screening in a Population at High Risk


Sponsor

Masaryk Memorial Cancer Institute

Enrollment

700 participants

Start Date

Jan 7, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria17

  • willing to participate in the study
  • age 18+
  • arms specific criteria:
  • A:
  • chronic pancreatic disease in the context of cystic fibrosis or chronic pancreatitis
  • age 50+
  • B1:
  • confirmed Peutz-Jegherson syndrome (mutSTK11) + age over 35 years or 10 years earlier than pancreatic ductal adenocarcinoma was diagnosed in the youngest family member
  • familial melanoma syndrome (mutCDKN2A) + age over 40 years or 10 years before pancreatic ductal adenocarcinoma was diagnosed in the youngest family member
  • confirmed hereditary pancreatitis (mutPRSS1) + age over 40 years or 20 years after the first attack
  • B2:
  • confirmed diagnosis of hereditary syndrome (Lynch syndrome /mutMLH1, mutMSH2, mutMSH6, mutPMS2, mutEPCAM/, HBOC /mutBRCA1, mutBRCA2, mutPALB2, mutATM/, familial adenomatous polyposis /mutAPC/, Li-Fraumeni syndrome /mutTP53/)
  • at least one relative with a diagnosis of pancreatic ductal adenocarcinoma in family anamnesis at the same time (Grade I or II relative)
  • age over 50 years, or 10 years before the pancreatic ductal adenocarcinoma was diagnosed in the youngest relative - which comes first
  • C:
  • positive family anamnesis of pancreatic ductal adenocarcinoma without hereditary syndrome context
  • age 50+ or 10 years earlier than the youngest relative with pancreatic ductal adenocarcinoma - screening is recommended for all first-degree relatives of affected family members

Exclusion Criteria3

  • Inability to undergo radical curative surgery for a pancreatic tumor.
  • Inability to undergo scheduled imaging examinations.
  • Incurable malignant cancer.

Interventions

PROCEDUREendoscopic ultrasonography

endoscopic ultrasonography - frequency defined by arm

PROCEDUREmagnetic resonance

magnetic resonance - frequency defined by arm

DIAGNOSTIC_TESTlaboratory examination

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


Locations(1)

Masaryk Memorial Cancer Institute

Brno, Czechia

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NCT06330441


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