Trial Title:
Pancreatic Cancer Screening in a Population at High Risk
NCT ID:
NCT06330441
Condition:
Pancreatic Ductal Adenocarcinoma
Hereditary Diseases
Pancreatitis, Chronic
Conditions: Official terms:
Adenocarcinoma
Pancreatitis
Pancreatitis, Chronic
Genetic Diseases, Inborn
Conditions: Keywords:
pancreatic ductal adenocarcinoma
screening programme
high-risk population
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
endoscopic ultrasonography
Description:
endoscopic ultrasonography - frequency defined by arm
Arm group label:
A - chronic pancreatitis
Arm group label:
B1 - genetic predisposition (STK11, CDKN2A, PRSS1)
Arm group label:
B2 - genetic predisposition of hereditary syndromes
Arm group label:
C - positive family anamnesis
Other name:
EUS
Intervention type:
Procedure
Intervention name:
magnetic resonance
Description:
magnetic resonance - frequency defined by arm
Arm group label:
A - chronic pancreatitis
Arm group label:
B1 - genetic predisposition (STK11, CDKN2A, PRSS1)
Arm group label:
B2 - genetic predisposition of hereditary syndromes
Arm group label:
C - positive family anamnesis
Other name:
MR
Intervention type:
Diagnostic Test
Intervention name:
laboratory examination
Description:
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
Arm group label:
A - chronic pancreatitis
Arm group label:
B1 - genetic predisposition (STK11, CDKN2A, PRSS1)
Arm group label:
B2 - genetic predisposition of hereditary syndromes
Arm group label:
C - positive family anamnesis
Other name:
LAB
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".
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Masaryk Memorial Cancer Institute
Address:
City:
Brno
Zip:
65653
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Martina Lojova, Ph.D.
Phone:
+420543136232
Email:
martina.lojova@mou.cz
Contact backup:
Last name:
Dita Kozakova, Ing.
Phone:
+420543136236
Email:
dita.kozakova@mou.cz
Investigator:
Last name:
Petr Karasek, MD
Email:
Principal Investigator
Investigator:
Last name:
Jana Halamkova, MD
Email:
Sub-Investigator
Investigator:
Last name:
Helena Coupkova, MD
Email:
Sub-Investigator
Investigator:
Last name:
Anna Ondrackova, MD
Email:
Sub-Investigator
Investigator:
Last name:
Marketa Palacova, MD
Email:
Sub-Investigator
Investigator:
Last name:
Radim Nemecek, MD
Email:
Sub-Investigator
Investigator:
Last name:
Lumir Kunovsky, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jan Trna, MD
Email:
Sub-Investigator
Investigator:
Last name:
Lenka Foretova, MD
Email:
Sub-Investigator
Investigator:
Last name:
Zdenka Cermakova, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jan Kristek, MD
Email:
Sub-Investigator
Investigator:
Last name:
Roman Hrstka, Ph.D.
Email:
Sub-Investigator
Start date:
January 7, 2022
Completion date:
January 6, 2028
Lead sponsor:
Agency:
Masaryk Memorial Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Masaryk University
Agency class:
Other
Source:
Masaryk Memorial Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06330441
