Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT04095195
Status:
RECRUITING
Last Update Posted:
2023-01-13
First Post:
2019-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Subjects at Risk of Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535837', 'term': 'Pancreatic carcinoma, familial'}, {'id': 'D003123', 'term': 'Colorectal Neoplasms, Hereditary Nonpolyposis'}, {'id': 'D004416', 'term': 'Dysplastic Nevus Syndrome'}, {'id': 'C537262', 'term': 'Hereditary pancreatitis'}, {'id': 'D010580', 'term': 'Peutz-Jeghers Syndrome'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D049914', 'term': 'DNA Repair-Deficiency Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009506', 'term': 'Nevus'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D007911', 'term': 'Lentigo'}, {'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2045-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2044-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This clinical study will assess the diagnostic yield of a clinical surveillance program for pancreatic neoplasia or predisposing conditions (PanIN, IPMNs) in high risk individuals', 'timeFrame': '25 years', 'description': 'Number of malignant and pre-malignant lesions diagnosed over time'}], 'secondaryOutcomes': [{'measure': 'This study will investigate possible risk factors for the incidence or the progression of for pancreatic neoplasia or predisposing conditions (PanIN, IPMNs) in high risk individuals', 'timeFrame': '25 years', 'description': 'Identification of risk factors for malignant or pre-malignant lesions diagnosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Familial Pancreatic Cancer', 'BRCA Mutation', 'Lynch Syndrome', 'Screening pancreatic cancer', 'Surveillance pancreatic cancer'], 'conditions': ['Familial Pancreatic Cancer', 'BRCA1 Mutation', 'BRCA2 Mutation', 'Lynch Syndrome', 'FAMMM - Familial Atypical Mole Malignant Melanoma Syndrome', 'Hereditary Pancreatitis', 'Peutz-Jeghers Syndrome']}, 'referencesModule': {'references': [{'pmid': '30538291', 'type': 'RESULT', 'citation': 'Paiella S, Capurso G, Cavestro GM, Butturini G, Pezzilli R, Salvia R, Signoretti M, Crippa S, Carrara S, Frigerio I, Bassi C, Falconi M, Iannicelli E, Giardino A, Mannucci A, Laghi A, Laghi L, Frulloni L, Zerbi A. Results of First-Round of Surveillance in Individuals at High-Risk of Pancreatic Cancer from the AISP (Italian Association for the Study of the Pancreas) Registry. Am J Gastroenterol. 2019 Apr;114(4):665-670. doi: 10.1038/s41395-018-0414-z.'}, {'pmid': '37787643', 'type': 'DERIVED', 'citation': 'Paiella S, Capurso G, Carrara S, Secchettin E, Casciani F, Frigerio I, Zerbi A, Archibugi L, Bonifacio C, Malleo G, Cavestro GM, Barile M, Larghi A, Assisi D, Fantin A, Milanetto AC, Fabbri C, Casadei R, Donato G, Sassatelli R, De Marchi G, Di Matteo FM, Arcangeli V, Panzuto F, Puzzono M, Dal Buono A, Pezzilli R, Salvia R, Rizzatti G, Casadio M, Franco M, Butturini G, Pasquali C, Coluccio C, Ricci C, Cicchese N, Sereni G, de Pretis N, Stigliano S, Rudnas B, Marasco M, Lionetto G, Arcidiacono PG, Terrin M, Crovetto A, Mannucci A, Laghi L, Bassi C, Falconi M. Outcomes of a 3-Year Prospective Surveillance in Individuals at High Risk of Pancreatic Cancer. Am J Gastroenterol. 2024 Apr 1;119(4):739-747. doi: 10.14309/ajg.0000000000002546. Epub 2023 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'IRFARPC is a multicenter national registry designed to study the diagnosis and predisposing factors of subjects with an inherited increased risk for pancreatic cancer.', 'detailedDescription': 'Pancreatic cancer is a devastating disease with a dismal prognosis. One of the ways to improve survival might be early detection.\n\nWithin years, many predisposing diseases or genetic conditions have been identified, thus screening/surveillance have been established worldwide.\n\nA registry of subjects at risk of pancreatic cancer will has been built up to investigate the possibility of diagnosis pancreatic cancer, or one if its predisposing lesions.\n\nInclusion criteria will be adopted as "enrollment criteria". According to this, individuals \\> 18 years old will be enrolled; their familiar history and/or genetic predisposition will be collected, as well as current or previous medical records/medications data. Thereafter, according to specific age-based criteria, those individuals initially enrolled will be will be considered for a "surveillance protocol" ("interventional follow-up criteria") and they will be submitted to Cholangio-Wirsung Magnetic Resonance or Pancreatic Endoultrasonography according to the pancreatologist\'s prescription at each participating center.\n\nIndividuals suffering from the following conditions will be enrolled:\n\nfamilial pancreatic cancer; Peutz-Jeghers syndrome; a known BRCA-2, BRCA-1, PALB2, or p16 mutation with at least one first- or second-degree relative suffering from pancreatic cancer; hereditary pancreatitis; FAMMM syndrome; Lynch syndrome with at least one first- or second-degree relative suffering from pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects at high-risk of pancreatic cancer will be enrolled and a surveillance examination will be performed according to inclusion criteria.', 'eligibilityCriteria': 'Inclusion Criteria to enter the registry:\n\n* individuals with at least two relatives suffering from pancreatic cancer, with at least 1 first-degree and until the third-degree\n* subjects with known genetic mutation of BRCA2, BRCA1, p16, PALB2 with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer\n* subjects suffering from FAMMM Syndrome\n* subjects suffering from Peutz-Jeghers Syndrome\n* subjects suffering from PRSS-1- or CFTR- or SPINK-1- related pancreatitis\n* subjects suffering from Lynch syndrome with at least 1 first- or 2nd-degree relative suffering from pancreatic cancer\n\nInclusion criteria to join the "radiologic follow-up":\n\n* 45 years or 10 years younger than the youngest index case of pancreatic cancer in the family for familial cases\n* 40 years or 5 years younger than the youngest index case of pancreatic cancer for subjects suffering from hereditary/genetic pancreatitis, Lynch syndrome, or carrying a known BRCA 1/2, PALB2, p16 genetic mutation with familiarity for pancreatic cancer\n* 30 years for subjects suffering from FAMMM, Peutz-Jeghers syndrome\n\nExclusion Criteria:\n\n\\- pregnancy'}, 'identificationModule': {'nctId': 'NCT04095195', 'acronym': 'IRFARPC', 'briefTitle': 'Registry of Subjects at Risk of Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Associazione Italiana per lo Studio del Pancreas'}, 'officialTitle': 'Italian Registry of Families At Risk of Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'IRFARPC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Familial pancreatic cancer relatives', 'interventionNames': ['Radiation: MRCP', 'Procedure: Endoultrasonography']}, {'label': 'Peutz-Jeghers syndrome', 'interventionNames': ['Radiation: MRCP', 'Procedure: Endoultrasonography']}, {'label': 'BRCA 1/2, PALB2, p16 mutations with familiarity for PC', 'description': 'Known genetic mutation and at least 1 1st- or 2nd-degree relative suffering from PC', 'interventionNames': ['Radiation: MRCP', 'Procedure: Endoultrasonography']}, {'label': 'Lynch syndrome with familiarity for pancreatic cancer', 'interventionNames': ['Radiation: MRCP', 'Procedure: Endoultrasonography']}, {'label': 'FAMMM syndrome', 'interventionNames': ['Radiation: MRCP', 'Procedure: Endoultrasonography']}, {'label': 'Hereditary and genetic pancreatitis', 'interventionNames': ['Radiation: MRCP', 'Procedure: Endoultrasonography']}], 'interventions': [{'name': 'MRCP', 'type': 'RADIATION', 'description': 'Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist\'s prescription', 'armGroupLabels': ['BRCA 1/2, PALB2, p16 mutations with familiarity for PC', 'FAMMM syndrome', 'Familial pancreatic cancer relatives', 'Hereditary and genetic pancreatitis', 'Lynch syndrome with familiarity for pancreatic cancer', 'Peutz-Jeghers syndrome']}, {'name': 'Endoultrasonography', 'type': 'PROCEDURE', 'description': 'Subjects fulfilling the "radiological follow-up criteria" will be submitted to MRCP or EUS according to the pancreatologist\'s prescription', 'armGroupLabels': ['BRCA 1/2, PALB2, p16 mutations with familiarity for PC', 'FAMMM syndrome', 'Familial pancreatic cancer relatives', 'Hereditary and genetic pancreatitis', 'Lynch syndrome with familiarity for pancreatic cancer', 'Peutz-Jeghers syndrome']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rozzano', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvia Carrara, MD', 'role': 'CONTACT', 'email': 'silvia.carrara@humanitas.it'}, {'name': 'Alessandro Zerbi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luigi Laghi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laura Poliani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Valentina Giatti', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Peschiera del Garda', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Butturini, MD', 'role': 'CONTACT'}, {'name': 'Alessandro Giardino, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Isabella Frigerio, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ospedale Pederzoli', 'geoPoint': {'lat': 45.43912, 'lon': 10.68614}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Falconi, MD', 'role': 'CONTACT', 'email': 'massimo.falconi@hsr.it'}, {'name': 'Gabriele Capurso, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Silvia Smaniotto', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'San Raffele Vita Salute University Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '37134', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Paiella, MD, PhD', 'role': 'CONTACT', 'email': 'salvatore.paiella@univr.it', 'phone': '00390458126009'}, {'name': 'Erica Secchettin, PharmD', 'role': 'CONTACT', 'email': 'erica.secchettin@univr.it', 'phone': '00390458126254'}, {'name': 'Salvatore Paiella, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Giuseppe Malleo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Claudio Bassi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Roberto Salvia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Erica Secchettin, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Veronica Marinelli, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chirurgia Generale e del Pancreas', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Salvatore Paiella, MD, PhD', 'role': 'CONTACT', 'email': 'salvatore.paiella@univr.it', 'phone': '00390458126009'}, {'name': 'Silvia Carrara, MD', 'role': 'CONTACT', 'email': 'silvia.carrara@humanitas.it', 'phone': '+ 39 02 82247288'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associazione Italiana per lo Studio del Pancreas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}