Pancreatic Ductal AdenocarcinomaScrePanNCT06330441
Pancreatic Cancer Screening in a Population at High Risk
A study testing endoscopic ultrasonography, magnetic resonance and laboratory examination in people with Pancreatic Ductal Adenocarcinoma and Hereditary Diseases, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Hereditary Diseases, Pancreatitis, Chronic
- What is being tested?
- endoscopic ultrasonography, magnetic resonance and laboratory examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Jan 2022to 6 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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+
Show all 17Show fewer
- 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
Who cannot join
- Inability to undergo radical curative surgery for a pancreatic tumor.
- Inability to undergo scheduled imaging examinations.
- Incurable malignant cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, 65653
Martina Lojova, Ph.D., +420543136232, martina.lojova@mou.cz
Dita Kozakova, Ing., +420543136236, dita.kozakova@mou.cz
About this study
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".
Read the 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.
- Being tested
- endoscopic ultrasonography, magnetic resonance, laboratory examination
- Keywords
- pancreatic ductal adenocarcinoma, screening programme, high-risk population
- Medical subject headings
- Genetic Diseases, Inborn, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasonographyProcedure or surgery
Also called EUS
endoscopic ultrasonography - frequency defined by arm
magnetic resonanceProcedure or surgery
Also called MR
magnetic resonance - frequency defined by arm
laboratory examinationDiagnostic test
Also called LAB
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
| Study group | Role | What they receive |
|---|---|---|
| A - chronic pancreatitis | Experimental | Chronic pancreatitis, due to cystic fibrosis Receives: Procedure: endoscopic ultrasonography; Procedure: magnetic resonance; Diagnostic Test: laboratory examination |
| B1 - genetic predisposition (STK11, CDKN2A, PRSS1) | Experimental | Persons with a confirmed diagnosis of Peutz-Jeghers syndrome (STK11 mutation) or familial melanoma syndrome (CDKN2A mutation), hereditary pancreatitis (PRSS1 mutation) Receives: Procedure: endoscopic ultrasonography; Procedure: magnetic resonance; Diagnostic Test: laboratory examination |
| B2 - genetic predisposition of hereditary syndromes | Experimental | 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) Receives: Procedure: endoscopic ultrasonography; Procedure: magnetic resonance; Diagnostic Test: laboratory examination |
| C - positive family anamnesis | Experimental | Persons with positive family anamnesis of pancreatic ductal adenocarcinoma without proven hereditary syndrome Receives: Procedure: endoscopic ultrasonography; Procedure: magnetic resonance; Diagnostic Test: laboratory examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with newly diagnosed pancreatic ductal adenocarcinoma
Number of participants (in risk population) with newly diagnosed pancreatic cancer
Measured: 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 (3)
Methods yield comparison
Comparison of magnetic resonance versus endoscopic ultrasonography yield
Measured: through study completion, an average of 1 year
Screening methods cost-effectiveness
Comparison of magnetic resonance versus endoscopic ultrasonography cost effectiveness
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start7 Jan 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion6 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330441
- Sponsor's protocol ID
- MOU-2021-01
- Acronym
- ScrePan
- Status last verified
- Oct 2026
- First submitted
- 31 Dec 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Canto MI, Harinck F, Hruban RH, Offerhaus GJ, Poley JW, Kamel I, Nio Y, Schulick RS, Bassi C, Kluijt I, Levy MJ, Chak A, Fockens P, Goggins M, Bruno M; International Cancer of Pancreas Screening (CAPS) Consortium. International Cancer of the Pancreas Screening (CAPS) Consortium summit on the management of patients with increased risk for familial pancreatic cancer. Gut. 2013 Mar;62(3):339-47. doi: 10.1136/gutjnl-2012-303108. Epub 2012 Nov 7.
PubMed 23135763Syngal S, Brand RE, Church JM, Giardiello FM, Hampel HL, Burt RW; American College of Gastroenterology. ACG clinical guideline: Genetic testing and management of hereditary gastrointestinal cancer syndromes. Am J Gastroenterol. 2015 Feb;110(2):223-62; quiz 263. doi: 10.1038/ajg.2014.435. Epub 2015 Feb 3.
PubMed 25645574Stoffel EM, McKernin SE, Brand R, Canto M, Goggins M, Moravek C, Nagarajan A, Petersen GM, Simeone DM, Yurgelun M, Khorana AA. Evaluating Susceptibility to Pancreatic Cancer: ASCO Provisional Clinical Opinion. J Clin Oncol. 2019 Jan 10;37(2):153-164. doi: 10.1200/JCO.18.01489. Epub 2018 Nov 20.
PubMed 30457921Abe T, Blackford AL, Tamura K, Ford M, McCormick P, Chuidian M, Almario JA, Borges M, Lennon AM, Shin EJ, Klein AP, Hruban RH, Canto MI, Goggins M. Deleterious Germline Mutations Are a Risk Factor for Neoplastic Progression Among High-Risk Individuals Undergoing Pancreatic Surveillance. J Clin Oncol. 2019 May 1;37(13):1070-1080. doi: 10.1200/JCO.18.01512. Epub 2019 Mar 18.
PubMed 30883245Bartsch DK, Slater EP, Carrato A, Ibrahim IS, Guillen-Ponce C, Vasen HF, Matthai E, Earl J, Jendryschek FS, Figiel J, Steinkamp M, Ramaswamy A, Vazquez-Sequeiros E, Munoz-Beltran M, Montans J, Mocci E, Bonsing BA, Wasser M, Kloppel G, Langer P, Fendrich V, Gress TM. Refinement of screening for familial pancreatic cancer. Gut. 2016 Aug;65(8):1314-21. doi: 10.1136/gutjnl-2015-311098. Epub 2016 May 24.
PubMed 27222532Harinck F, Konings IC, Kluijt I, Poley JW, van Hooft JE, van Dullemen HM, Nio CY, Krak NC, Hermans JJ, Aalfs CM, Wagner A, Sijmons RH, Biermann K, van Eijck CH, Gouma DJ, Dijkgraaf MG, Fockens P, Bruno MJ; Dutch research group on pancreatic cancer surveillance in high-risk individuals. A multicentre comparative prospective blinded analysis of EUS and MRI for screening of pancreatic cancer in high-risk individuals. Gut. 2016 Sep;65(9):1505-13. doi: 10.1136/gutjnl-2014-308008. Epub 2015 May 18.
PubMed 25986944Corral JE, Das A, Bruno MJ, Wallace MB. Cost-effectiveness of Pancreatic Cancer Surveillance in High-Risk Individuals: An Economic Analysis. Pancreas. 2019 Apr;48(4):526-536. doi: 10.1097/MPA.0000000000001268.
PubMed 30946242Vasen H, Ibrahim I, Ponce CG, Slater EP, Matthai E, Carrato A, Earl J, Robbers K, van Mil AM, Potjer T, Bonsing BA, de Vos Tot Nederveen Cappel WH, Bergman W, Wasser M, Morreau H, Kloppel G, Schicker C, Steinkamp M, Figiel J, Esposito I, Mocci E, Vazquez-Sequeiros E, Sanjuanbenito A, Munoz-Beltran M, Montans J, Langer P, Fendrich V, Bartsch DK. Benefit of Surveillance for Pancreatic Cancer in High-Risk Individuals: Outcome of Long-Term Prospective Follow-Up Studies From Three European Expert Centers. J Clin Oncol. 2016 Jun 10;34(17):2010-9. doi: 10.1200/JCO.2015.64.0730. Epub 2016 Apr 25.
PubMed 27114589Canto MI, Almario JA, Schulick RD, Yeo CJ, Klein A, Blackford A, Shin EJ, Sanyal A, Yenokyan G, Lennon AM, Kamel IR, Fishman EK, Wolfgang C, Weiss M, Hruban RH, Goggins M. Risk of Neoplastic Progression in Individuals at High Risk for Pancreatic Cancer Undergoing Long-term Surveillance. Gastroenterology. 2018 Sep;155(3):740-751.e2. doi: 10.1053/j.gastro.2018.05.035. Epub 2018 May 24.
PubMed 29803839Dbouk M, Katona BW, Brand RE, Chak A, Syngal S, Farrell JJ, Kastrinos F, Stoffel EM, Blackford AL, Rustgi AK, Dudley B, Lee LS, Chhoda A, Kwon R, Ginsberg GG, Klein AP, Kamel I, Hruban RH, He J, Shin EJ, Lennon AM, Canto MI, Goggins M. The Multicenter Cancer of Pancreas Screening Study: Impact on Stage and Survival. J Clin Oncol. 2022 Oct 1;40(28):3257-3266. doi: 10.1200/JCO.22.00298. Epub 2022 Jun 15.
PubMed 35704792Sawhney MS, Calderwood AH, Thosani NC, Rebbeck TR, Wani S, Canto MI, Fishman DS, Golan T, Hidalgo M, Kwon RS, Riegert-Johnson DL, Sahani DV, Stoffel EM, Vollmer CM Jr, Qumseya BJ; Prepared by: ASGE STANDARDS OF PRACTICE COMMITTEE. ASGE guideline on screening for pancreatic cancer in individuals with genetic susceptibility: summary and recommendations. Gastrointest Endosc. 2022 May;95(5):817-826. doi: 10.1016/j.gie.2021.12.001. Epub 2022 Feb 16. No abstract available.
PubMed 35183358