{"registry": "ISRCTN", "registryId": "ISRCTN14879538", "source": "https://www.isrctn.com/ISRCTN14879538", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN14879538/format/default", "fetchedAt": "2026-10-07T17:01:23.210751Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "Precision Panc: Advancing personalised medicine treatment strategies for pancreatic cancer", "scientificTitle": "Precision Panc Master Protocol: Personalising Treatment for Pancreatic Cancer", "acronym": "Precision Panc", "hypothesis": "The overall framework of Precision-Panc aims to accelerate stratified therapeutic development though co-ordination, data sharing and aligned decision-making. This UK-wide Master Protocol will enable the screening and molecular profiling of patients with pancreatic cancer, embedded within the standard diagnostic pathway to subsequent enrolment in available Pancreatic canceR Individualised Multi-arm Umbrella Study (PRIMUS) studies. PRIMUS is the set of clinical trials where patients may be recruited to the most suitable treatment studies based on their molecular phenotype and/or integrated with biomarker discovery and validation approaches. We aim to create a patient-focused environment where attractive trial options are offered to as many patients and their treating clinicians as possible. The aim is to identify the right trial for the patient, rather than current approaches where we search for patients for a specific trial. By offering a range of attractive options for patients and clinicians, we envisage significant increases in recruitment. In addition, Precision-Panc will also provide a platform for drug development in partnership with industry, by screening and identifying subgroup of patients with candidate biomarker of therapeutic responsiveness.\n\nThe outcomes of the patients will be recorded on the Master Protocol or the PRIMUS studies. Precision-Panc Master Protocol will serve not only as a molecular profiling platform for PRIMUS clinical trials, but also a translational research platform. The molecular profiling data generated along with the outcome data will be essential in the delineation of molecular mechanisms important in the pathophysiology of pancreatic cancer. This in turn will provide significant opportunities to understand the molecular pathology of pancreatic cancer better, and to identify candidate biomarkers for available therapeutic options and define therapeutic targets for novel drug development.", "primaryOutcome": "To establish a mechanism and framework to recruit and screen patients with pancreatic cancer to perform molecular profiling, evaluation of circulating biomarkers and allow enrolment to Precision Panc PRIMUS studies.  This will be measured by the number of patients screened and registered to the study and the number of patients where a molecular profile is obtained.  The number of patients registered to Precision Panc who then go onto a PRIMUS study will also be measured", "secondaryOutcome": "1. To assess the overall survival (OS) in patients enrolled in Precision-Panc and relate this to molecular profile information\n2. To assess the safety of obtaining tumour biopsies suitable for molecular profiling within a standard patient treatment pathway\n3. To establish a central repository of molecular profiles with accompanying phenotypic data and accompanying biospecimens for further translational research\n4. To establish a dynamic platform for evaluation of circulating biomarkers to subsequently inform design of subsequent clinical studies", "intervention": "\n\tPatients with either suspected or confirmed pancreatic cancer are approached to take part in the study and given the Precision Panc Screening PIS. Participants are given time to consider trial participation and if they are willing to take part in the study they are screened onto the study. If the patient has suspected pancreatic cancer and are having a standard of care diagnostic biopsy, extra cores are taken at that time for the Precision Panc study. If pancreatic ductal adenocarcinoma is confirmed the patient are then given the registration PIS/consent which allows for molecular profiling to take place on the extra tissue taken for research. If the patient already has a diagnosis of pancreatic ductal adenocarcinoma they are asked to undergo and additional research biopsy for the study. All participants are also asked to provide a blood sample for research. The tissue (either the extra diagnostic tissue or the research biopsy) and blood sample are sent to Glasgow for molecular profiling and if enough tissue is available for profiling they may be eligible for an open PRIMUS study.\n\tProcedure/Surgery\n\t\n\t\n      ", "condition": "\n\tPancreatic Cancer\n\tCancer\n\tPancreatic Cancer\n      ", "studyDesign": "Interventional non randomised study", "overallEndDate": "2022-03-30T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2021-09-20T10:19:17.837Z", "eligibility": {"inclusion": "1. Adult patients (age >16 years)\n2. With either:\n2.1. Presence of a hypodense pancreatic mass highly suspicious of primary pancreatic cancer with or without distant metastasis as assessed by a Pancreatic Multi-Disciplinary Team (MDT) or\n2.2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants\n3. Patient is willing and able to undergo tumour biopsy aimed at obtaining sufficient tissue for molecular profiling\n4. Patient is deemed suitable to receive chemotherapy and/or radiotherapy, and/or surgery pending stage of disease at presentation\n5. Signed informed consent for screening research tumour biopsy (Consent 1)\n6. Signed informed consent for Precision-Panc Master Protocol molecular profiling (Consent 2)", "exclusion": "There is no participant exclusion criteria.", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2017-12-14T00:00:00.000Z", "recruitmentEnd": "2022-03-29T00:00:00.000Z", "recruitmentStatusOverride": "Suspended", "recruitmentStartStatusOverride": "", "targetEnrolment": "5000", "totalFinalEnrolment": ""}, "countries": ["United Kingdom", "England", "Northern Ireland", "Scotland"], "locations": [{"name": "Glasgow Royal Infirmary", "city": "Glasgow", "state": "", "country": "United Kingdom", "zip": "G4 0SF"}, {"name": "Aberdeen Royal Infirmary", "city": "Aberdeen", "state": "", "country": "United Kingdom", "zip": "AB25 2ZN"}, {"name": "Royal Marsden Hospital", "city": "London", "state": "", "country": "United Kingdom", "zip": "SW3 6JJ"}, {"name": "UCLH", "city": "London", "state": "", "country": "United Kingdom", "zip": "NW1 2BU"}, {"name": "Addenbrookes Hospital", "city": "Cambridge", "state": "", "country": "United Kingdom", "zip": "CB2 0QQ."}, {"name": "Christie, Manchester", "city": "Manchester", "state": "", "country": "United Kingdom", "zip": "M20 4BX"}, {"name": "Weston Park", "city": "Sheffield", "state": "", "country": "United Kingdom", "zip": "S10 2SJ"}, {"name": "Bristol Oncology Centre", "city": "Bristol", "state": "", "country": "United Kingdom", "zip": "S10 2SJ"}, {"name": "Imperial College London", "city": "London", "state": "", "country": "United Kingdom", "zip": "SW7 2BX"}, {"name": "Nottingham University Healthcare Trust", "city": "Nottingham", "state": "", "country": "United Kingdom", "zip": "NG5 1PB"}, {"name": "Royal Free London Hospital", "city": "London", "state": "", "country": "United Kingdom", "zip": "NW3 2QG"}, {"name": "Ninewells Hospital", "city": "Dundee", "state": "", "country": "United Kingdom", "zip": "DD2 1UB"}, {"name": "St George's Hospital", "city": "London", "state": "", "country": "United Kingdom", "zip": "SW17 0QT"}, {"name": "Southampton University Hospital", "city": "Southampton", "state": "", "country": "United Kingdom", "zip": "SO16 6YD"}, {"name": "Queen Elizabeth Hospital Birmingham", "city": "Birmingham", "state": "", "country": "United Kingdom", "zip": "B15 2WB"}, {"name": "King's College Hospital", "city": "London", "state": "", "country": "United Kingdom", "zip": "SE5 9RS"}, {"name": "Churchill Hospital", "city": "Oxford", "state": "", "country": "United Kingdom", "zip": "OX3 7LE"}, {"name": "Castle Hill Hospital", "city": "Cottingham", "state": "", "country": "United Kingdom", "zip": "HU16 5JQ"}, {"name": "Poole Hospital", "city": "Poole", "state": "", "country": "United Kingdom", "zip": "BH15 2JB"}, {"name": "Freeman Hospital", "city": "Newcastle", "state": "", "country": "United Kingdom", "zip": "NE7 7DN"}, {"name": "Royal Bournemouth Hospital", "city": "Bournemouth", "state": "", "country": "United Kingdom", "zip": "BH7 7DW"}, {"name": "Royal Albert Edward Infirmary", "city": "Wigan", "state": "", "country": "United Kingdom", "zip": "WN1 2NN"}, {"name": "Northern Ireland Cancer Centre", "city": "Belfast", "state": "", "country": "United Kingdom", "zip": "BT9 7JL"}, {"name": "Western General Infirmary", "city": "Edinburgh", "state": "", "country": "United Kingdom", "zip": "EH4 2XU"}, {"name": "Raigmore Hospital", "city": "Inverness", "state": "", "country": "United Kingdom", "zip": "IV2 3DZ"}, {"name": "Royal Liverpool Hospital", "city": "Liverpool", "state": "", "country": "United Kingdom", "zip": "L7 8XP"}, {"name": "Huddersfield Royal Infirmary", "city": "Huddersfield", "state": "", "country": "United Kingdom", "zip": "HD3 3EA"}], "sponsors": [{"organisation": "NHS Greater Glasgow and Clyde", "sponsorType": "Hospital/treatment centre", "rorId": "https://ror.org/05kdz4d87"}], "funders": [{"name": "CRUK"}, {"name": "Celgene", "fundRef": "http://dx.doi.org/10.13039/100006436"}]}, "studySha256": "712cdcb7db91f761c5ad7bca86f6eb47afeaf8fa07b581cd9e53babd47391505"}