Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-30 @ 8:21 AM
Study NCT ID:
NCT05724992
Status:
RECRUITING
Last Update Posted:
2023-02-15
First Post:
2022-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Familial Pancreatic Cancer PROPHilation Program in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2028-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2022-12-20', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence - absence of predisposing mutations', 'timeFrame': '5 years', 'description': 'Prevalence of genetic mutations over the total tested'}], 'secondaryOutcomes': [{'measure': 'Correlation of genetic mutations with personal oncological history', 'timeFrame': '5 years', 'description': 'Correlation between presence of predisposing mutation and prevalence of cancers'}, {'measure': 'Correlation of genetic mutations with familial oncological history', 'timeFrame': '5 years', 'description': 'Correlation between presence of predisposing mutation and prevalence of cancers in the family'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'Pancreatic Cancer familiarity', 'Genetic profiling', 'Genetic predisposition', 'Pancreatic Cancer surveillance'], 'conditions': ['Candidates for Hereditary Pancreatic Cancer Testing']}, 'descriptionModule': {'briefSummary': 'The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). This investigational study will assess the genetic background of subjects with familiarity with pancreatic cancer only.\n\nParticipants may accept to undergo genetic testing as part of the IRFARPC registry, through a saliva-swab-based 41-gene panel test.\n\nUp to 3,000 participants will be enrolled in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being enrolled on the IRFARPC registry\n* Having familiarity for pancreatic cancer (according to the IRFARPC criteria, Capurso et al. Dig Liv Dis, 2020)\n* Willingness to participate in saliva-swab-based genetic testing\n\nExclusion Criteria:\n\n\\- Already known genetic mutation'}, 'identificationModule': {'nctId': 'NCT05724992', 'acronym': 'PROPH-ITA', 'briefTitle': 'Familial Pancreatic Cancer PROPHilation Program in Italy', 'organization': {'class': 'OTHER', 'fullName': 'Associazione Italiana per lo Studio del Pancreas'}, 'officialTitle': 'Standardised Genetic Profiling of Subjects Belonging to the Italian Multicenter Registry of Prospective Surveillance of Subjects at Genetic Risk of Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'PROPH-ITA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Saliva testing swab', 'description': 'Subjects with familiarity with pancreatic cancer enrolled into the IRFARPC registry (NCT04095195) will be submitted to buccal swab for saliva-based genetic testing', 'interventionNames': ['Genetic: Saliva swab testing']}], 'interventions': [{'name': 'Saliva swab testing', 'type': 'GENETIC', 'description': '41 pancreatic cancer predisposition genes will be tested through a saliva-based swab', 'armGroupLabels': ['Saliva testing swab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37136', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Paiella, MD, PhD', 'role': 'CONTACT', 'email': 'salvatore.paiella@univr.it', 'phone': '+390458126009'}, {'name': 'Erica Secchettin, PharmD', 'role': 'CONTACT', 'email': 'erica.secchettin@univr.it', 'phone': '+390458126254'}], 'facility': 'Chirurgia generale e del Pancreas Azienda Ospedaliera Universitaria Integrata', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Erica Secchettin, PharmD', 'role': 'CONTACT', 'email': 'familiarita.aisp@gmail.com', 'phone': '0458126254'}, {'name': 'AISP Association', 'role': 'CONTACT', 'email': 'aisp.ricerca@gmail.com', 'phone': '340 2713112'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associazione Italiana per lo Studio del Pancreas', 'class': 'OTHER'}, 'collaborators': [{'name': 'General and Pancreatic Surgery Unit, University of Verona', 'class': 'UNKNOWN'}, {'name': 'Fondazione Valsecchi', 'class': 'UNKNOWN'}, {'name': 'Associazione Oltre La Ricerca', 'class': 'UNKNOWN'}, {'name': 'Genomica srl', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}