{"registry": "ISRCTN", "registryId": "ISRCTN62546421", "source": "https://www.isrctn.com/ISRCTN62546421", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN62546421/format/default", "fetchedAt": "2026-10-07T17:00:57.212177Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "The European registry of familial pancreatic cancer and hereditary pancreatitis", "scientificTitle": "Primary and secondary screening in individuals with inherited pancreatic disease syndromes for pancreatic ductal adenocarcinoma and complications of other pancreatic diseases", "acronym": "EUROPAC", "hypothesis": "The EUROPAC study has been productive, producing 19 publications in the last 5 years alone. However, some of our principal objectives have not yet been met. Most importantly we have not yet identified an effective modality for early detection of pancreatic cancer. One reason for this is ongoing technological developments; the tools available to us now were not available when EUROPAC started (in the 1990s). The other reason is simply the lack of outcomes to date. Validating methods for detecting early pancreatic cancer requires prospective events. We observe 5 cancer cases per year in the familial pancreatic cancer (FPC) cohort of families and one case of pancreatic cancer in the hereditary pancreatitis (HP) group every 2 years. Unfortunately, these have mostly been in individuals who were not on our screening programme or indeed registered with EUROPAC.\n\nThe rationale for continuing the EUROPAC study is that we can now improve our recruitment practices to enrich for incident cases within our group of registered individuals. The epidemiological and demographic data we have already acquired and (in some cases) published will be used for stratification of cancer risk. We will also benefit from improved methods of pancreatic imaging including advances in end luminal ultrasound, computed tomography and magnetic resonance imaging. There are also new biomarkers available, which we will be able to test and, following validation, could be used to phase subsequent screening. \n\nContinuing the study will also allow us to further develop our study of disease progression. There is no limitation of cases for this aim and recruitment of further patients will allow models to be refined and improved. We therefore wish to continue recruitment to this registry and to continue to pilot secondary screening for pancreatic cancer in the individuals registered. The registry has also proved an invaluable resource for studying pancreatic diseases in general, including diabetes, acute and chronic pancreatitis as well as cancer. We also wish to continue this analysis, monitoring disease progression from acute pancreatitis to chronic pancreatitis with endocrine and exocrine failure.", "primaryOutcome": "Number of early-stage (stage 0, 1 or 2) pancreatic cancers found, measured at baseline CT scan and at subsequent screening investigations (yearly)", "secondaryOutcome": "1. Number of late-stage (stage 3 or 4) pancreatic cancers found, measured at baseline CT scan and at subsequent screening investigations (yearly)\n2. Number of actionable lesions found, measured at baseline CT scan and at subsequent screening investigations (yearly)", "intervention": "\n\tEUROPAC, although having international reach is described in relation to the UK.  This national prospective observational study has been running for several decades but has been modified into the current trial in 2019, which aims to recruit and screen 10,000 individuals with either familial pancreatic cancer (FPC) or hereditary pancreatitis (HP). Applicants are assessed for eligibility by generating an individual pedigree and by attributing a family risk score (FS). Those with an FS >30 are offered baseline imaging and then 3-yearly triplets of endoscopic ultrasound (EUS) yearly, and a magnetic resonance scan (MRI) (in the third year). Those with an FR >60 are offered both EUS and MRI yearly. Biospecimens are collected at registration to support future biomarker development and detect pancreatic cancer early. \n\tOther\n\t\n\t\n      ", "condition": "\n\tPancreatic ductal adenocarcinoma (PDAC)\n\tCancer\n\t\n      ", "studyDesign": "Observational registry", "overallEndDate": "2039-07-01T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2025-04-04T14:27:42.535879458Z", "eligibility": {"inclusion": "Inclusion Criteria for Registry:\n1. Two first-degree relatives with pancreatic adenocarcinoma\n2. A family with three or more relatives with pancreatic ductal adenocarcinoma.\n3. Families with pancreatic cancer and other cancers (e.g. bowel, breast/ovarian, melanoma, gastric) that suggest a known cancer predisposition syndrome.\n4. Families with a known inherited cancer syndrome (e.g. Hereditary Non-Polyposis Colorectal Cancer [HNPCC], familial atypical multiple mole melanoma [FAMMM], Lynch syndrome) with one individual affected by pancreatic cancer\n5. Peutz-Jeghers syndrome\n6. Families with a causative gene linked to pancreatic cancer (e.g. BRCA2 or yet undiscovered genes) and at least one case of pancreatic cancer in the family.\n7. Families with two or more relatives with idiopathic pancreatitis.\n8. Families with at least one case of pancreatitis and a confirmed causative mutation in the PRSS1 gene.\n\nInclusion Criteria for Screening:\n1. Individuals over 40 years of age from an established pancreatic cancer family. Inheritance of predisposition consistent with high penetrant autosomal dominant inheritance. For example, at least two first-degree relatives with pancreatic ductal adenocarcinoma, where no non-penetrant carriers have to be assumed over the age of 75.\n2. Unaffected member of a family with an associated cancer syndrome and at least one case of pancreatic cancer, who has been shown to carry the relevant genetic alteration.\n3. Any member of a hereditary pancreatitis family who has been confirmed to carry a causative PRSS1 mutation.\n4. An affected member of a family consistent with HP who has tested negative for known causative PRSS1 mutations.\n5. Individuals incidentally found to have cystic lesions or other clinical features that indicate an increased risk of pancreatic cancer may also be included.\n6. There will be adaptation to risk models as the study progresses to fit the needs of the study outcomes as the study progresses.\n\n", "exclusion": "1. Any participant who is incapable of providing informed consent. \n2. For genetic testing: Any individual who does not consent to be informed of clinically significant results. Genetic testing for a predisposition for pancreatitis will still be carried out on individuals who have expressed a wish not to be informed following detailed discussions on the limitations of a right not to know in this case; testing will be carried out only if individuals wish to have testing just for research.\n3. For screening: Individuals of less than 40 years of age or 10 years younger than the youngest case in the family will be excluded.\n4. For screening: Any individual deemed to have less than a 2% chance of developing PDAC in the next three years will be excluded. This will depend on the evidence supporting the models and the exclusion will only apply if the steering committee agrees on the risk assessment. A risk assessment will be made using progressively developed models. \n5. For screening: Any female participant able to bear a child but who has not taken appropriate contraceptive measures.", "ageRange": "All", "gender": "All", "participantType": "Population"}, "recruitment": {"recruitmentStart": "2019-07-01T00:00:00.000Z", "recruitmentEnd": "2039-07-01T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "10000", "totalFinalEnrolment": ""}, "countries": ["United Kingdom", "England", "Northern Ireland", "Scotland", "Wales"], "locations": [{"name": "Royal Liverpool and Broadgreen University Hospitals NHS Trust", "city": "Liverpool", "state": "", "country": "United Kingdom", "zip": "L7 8XP"}, {"name": "Glasgow Royal Infirmary", "city": "Glasgow", "state": "", "country": "United Kingdom", "zip": "G4 0SF"}, {"name": "The Freeman Group of Hospitals NHS Trust", "city": "Newcastle upon Tyne", "state": "", "country": "United Kingdom", "zip": "NE7 7DN"}, {"name": "Leeds Teaching Hospitals NHS Trust", "city": "Leeds", "state": "", "country": "United Kingdom", "zip": "LS9 7TF"}, {"name": "Nottingham University Hospitals NHS Trust - City Campus", "city": "Nottingham", "state": "", "country": "United Kingdom", "zip": "NG5 1PB"}, {"name": "Morriston Hospital", "city": "Swansea", "state": "", "country": "United Kingdom", "zip": "SA6 6NL"}, {"name": "Bristol Royal Infirmary", "city": "Bristol", "state": "", "country": "United Kingdom", "zip": "BS2 8HW"}, {"name": "Plymouth Hospitals NHS Trust", "city": "Plymouth", "state": "", "country": "United Kingdom", "zip": "PL6 8DH"}, {"name": "University Hospital Southampton NHS Foundation Trust", "city": "Southampton", "state": "", "country": "United Kingdom", "zip": "SO16 6YD"}, {"name": "Uclh", "city": "London", "state": "", "country": "United Kingdom", "zip": "NW1 2PQ"}], "sponsors": [{"organisation": "University of Liverpool", "sponsorType": "University/education", "rorId": "https://ror.org/04xs57h96"}], "funders": [{"name": "NHS England"}, {"name": "Pancreatic Cancer UK", "fundRef": "http://dx.doi.org/10.13039/100009795"}, {"name": "Cheshire and Merseyside Cancer Alliance"}]}, "studySha256": "020b07940fe34bed4237b123cb73c88cfa13898900d006520cc29dae6a7b155a"}