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2022-01-07
2025-01-06
2028-01-06
700
NCT06330441
Masaryk Memorial Cancer Institute
Masaryk Memorial Cancer Institute
INTERVENTIONAL
Pancreatic Cancer Screening in a Population at High Risk
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-12-31 | N/A | 2024-03-29 |
2024-03-19 | N/A | 2024-04-01 |
2024-03-26 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Screening
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: A - chronic pancreatitis Chronic pancreatitis, due to cystic fibrosis | PROCEDURE: endoscopic ultrasonography
PROCEDURE: magnetic resonance
DIAGNOSTIC_TEST: laboratory examination
|
| 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
PROCEDURE: magnetic resonance
DIAGNOSTIC_TEST: laboratory examination
|
| 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: M | PROCEDURE: endoscopic ultrasonography
PROCEDURE: magnetic resonance
DIAGNOSTIC_TEST: laboratory examination
|
| EXPERIMENTAL: C - positive family anamnesis Persons with positive family anamnesis of pancreatic ductal adenocarcinoma without proven hereditary syndrome | PROCEDURE: endoscopic ultrasonography
PROCEDURE: magnetic resonance
DIAGNOSTIC_TEST: laboratory examination
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of participants with newly diagnosed pancreatic ductal adenocarcinoma | 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 | Measure Description | Time Frame |
|---|---|---|
| Methods yield comparison | Comparison of magnetic resonance versus endoscopic ultrasonography yield | through study completion, an average of 1 year |
| Screening methods cost-effectiveness | Comparison of magnetic resonance versus endoscopic ultrasonography cost effectiveness | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Martina Lojova, Ph.D. Phone Number: +420543136232 Email: martina.lojova@mou.cz |
Study Contact Backup Name: Dita Kozakova, Ing. Phone Number: +420543136236 Email: dita.kozakova@mou.cz |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
