Pancreatic Cancer Screening in a Population at High Risk

NCT06330441 | Recruiting

• 1 other identifier: MOU-2021-01
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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".

Conditions

Pancreatic Ductal Adenocarcinoma; Hereditary Diseases; Pancreatitis, Chronic

Keywords

pancreatic ductal adenocarcinoma; screening programme; high-risk population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Methods yield comparison

  through study completion, an average of 1 year

• Screening methods cost-effectiveness

  through study completion, an average of 1 year

• KRAS mutation status evaluation

  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

Study Arms (4)

A - chronic pancreatitis

EXPERIMENTAL

Chronic pancreatitis, due to cystic fibrosis

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)

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)

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

Procedure: endoscopic ultrasonography; Procedure: magnetic resonance; Diagnostic Test: laboratory examination

Interventions

endoscopic ultrasonography PROCEDURE

endoscopic ultrasonography - frequency defined by arm

Also known as: EUS

A - chronic pancreatitis; B1 - genetic predisposition (STK11, CDKN2A, PRSS1); B2 - genetic predisposition of hereditary syndromes; C - positive family anamnesis

magnetic resonance PROCEDURE

magnetic resonance - frequency defined by arm

Also known as: MR

A - chronic pancreatitis; B1 - genetic predisposition (STK11, CDKN2A, PRSS1); B2 - genetic predisposition of hereditary syndromes; C - positive family anamnesis

laboratory examination DIAGNOSTIC_TEST

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

Also known as: LAB

A - chronic pancreatitis; B1 - genetic predisposition (STK11, CDKN2A, PRSS1); B2 - genetic predisposition of hereditary syndromes; C - positive family anamnesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• willing to participate in the study
• age 18+
• arms specific criteria:
• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Masaryk Memorial Cancer Institute: lead
• Masaryk University: collaborator

Study Sites (1)

Masaryk Memorial Cancer Institute

Brno, 65653, Czechia

RECRUITING

Related Publications (11)

• 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.

  PMID: 23135763 BACKGROUND

• Syngal 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.

  PMID: 25645574 BACKGROUND

• Stoffel 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.

  PMID: 30457921 BACKGROUND

• Abe 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.

  PMID: 30883245 BACKGROUND

• Bartsch 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.

  PMID: 27222532 BACKGROUND

• Harinck 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.

  PMID: 25986944 BACKGROUND

• Corral 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.

  PMID: 30946242 BACKGROUND

• Vasen 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.

  PMID: 27114589 BACKGROUND

• Canto 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.

  PMID: 29803839 BACKGROUND

• Dbouk 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.

  PMID: 35704792 BACKGROUND

• Sawhney 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.

  PMID: 35183358 BACKGROUND

MeSH Terms

Conditions

Genetic Diseases, Inborn; Pancreatitis, Chronic

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Martina Lojova, Ph.D.

CONTACT

+420543136232; martina.lojova@mou.cz

Dita Kozakova, Ing.

CONTACT

+420543136236; dita.kozakova@mou.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: March 26, 2024
• Study Start: January 7, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 6, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

CZ (1)