Pancreatic Cancer Screening in a Population at High Risk (ScrePan)

March 29, 2024 updated by: Masaryk Memorial Cancer Institute
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".

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia, 65653
        • Recruiting
        • Masaryk Memorial Cancer Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Petr Karasek, MD
        • Sub-Investigator:
          • Jana Halamkova, MD
        • Sub-Investigator:
          • Helena Coupkova, MD
        • Sub-Investigator:
          • Anna Ondrackova, MD
        • Sub-Investigator:
          • Marketa Palacova, MD
        • Sub-Investigator:
          • Radim Nemecek, MD
        • Sub-Investigator:
          • Lumir Kunovsky, MD
        • Sub-Investigator:
          • Jan Trna, MD
        • Sub-Investigator:
          • Lenka Foretova, MD
        • Sub-Investigator:
          • Zdenka Cermakova, MD
        • Sub-Investigator:
          • Jan Kristek, MD
        • Sub-Investigator:
          • Roman Hrstka, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A - chronic pancreatitis
Chronic pancreatitis, due to cystic fibrosis
Procedure: endoscopic ultrasonography
endoscopic ultrasonography - frequency defined by arm
Other Names:
  • EUS
Procedure: magnetic resonance
magnetic resonance - frequency defined by arm
Other Names:
  • MR
Diagnostic test: laboratory 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
Other Names:
  • LAB
Experimental: B1 - genetic predisposition (STK11, CDKN2A, PRSS1)
Persons with a confirmed diagnosis of Peutz-Jeghers syndrome (STK11 mutation) or familial melanoma syndrome (CDKN2A mutation), hereditary pancreatitis (PRSS1 mutation)
Procedure: endoscopic ultrasonography
endoscopic ultrasonography - frequency defined by arm
Other Names:
  • EUS
Procedure: magnetic resonance
magnetic resonance - frequency defined by arm
Other Names:
  • MR
Diagnostic test: laboratory 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
Other Names:
  • LAB
Experimental: B2 - genetic predisposition of hereditary syndromes
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
endoscopic ultrasonography - frequency defined by arm
Other Names:
  • EUS
Procedure: magnetic resonance
magnetic resonance - frequency defined by arm
Other Names:
  • MR
Diagnostic test: laboratory 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
Other Names:
  • LAB
Experimental: C - positive family anamnesis
Persons with positive family anamnesis of pancreatic ductal adenocarcinoma without proven hereditary syndrome
Procedure: endoscopic ultrasonography
endoscopic ultrasonography - frequency defined by arm
Other Names:
  • EUS
Procedure: magnetic resonance
magnetic resonance - frequency defined by arm
Other Names:
  • MR
Diagnostic test: laboratory 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
Other Names:
  • LAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with newly diagnosed pancreatic ductal adenocarcinoma
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
Number of participants (in risk population) with newly diagnosed pancreatic cancer
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methods yield comparison
Time Frame: through study completion, an average of 1 year
Comparison of magnetic resonance versus endoscopic ultrasonography yield
through study completion, an average of 1 year
Screening methods cost-effectiveness
Time Frame: through study completion, an average of 1 year
Comparison of magnetic resonance versus endoscopic ultrasonography cost effectiveness
through study completion, an average of 1 year
KRAS mutation status evaluation
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
KRAS mutation status defined by number of positive droplets on drop digital PCR using material from liquid biopsy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk Memorial Cancer Institute

Collaborators

Masaryk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2022

Primary Completion (Estimated)

January 6, 2025

Study Completion (Estimated)

January 6, 2028

Study Registration Dates

First Submitted

December 31, 2023

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOU-2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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