Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT02665494
Status:
UNKNOWN
Last Update Posted:
2016-09-23
First Post:
2016-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2016-01-24', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment the prevalence of a broad pool of medical or non-medical (e.g. life-style) conditions among Italian patients with cholangiocarcinoma, in order to evaluate their potential role as a risk factor', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cholangiocarcinoma']}, 'descriptionModule': {'briefSummary': 'Multi-centric, observational, prospective study, designed for pts with diagnosis of all-stages cholangiocarcinoma, including rare and crossing-over histological types, and excluding gallbladder cancer and ampullary carcinoma.', 'detailedDescription': 'Patients will undergo basal blood sample exams regarding blood cell count, renal and liver function, tumor markers, inflammatory and metabolic state, along with a screening (and, if needed, a more in-depth laboratory analysis) for viral hepatitis infections. Information will be collected about radiological, clinical and pathological features of the neoplasm at time of diagnosis, as well, at a later time, about its natural history. A two-step data analysis will be performed: Task-1 analysis will define the risk factors landscape, Task-2 analysis will examine the influence of etiology on clinical outcomes. Anonymized data will be stored in a central database, kept at the Leading Centre.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with diagnosis of all-stages cholangiocarcinoma, including rare and crossing-over histological types, and excluding gallbladder cancer and ampullary carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* voluntary, written, dated and signed informed consent;\n* age ≥ 18 years;\n* histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms). Neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma.\n\nExclusion Criteria:\n\n* Dementia or altered mental status leading to inability to understand or render the informed consent.\n* Patients who already underwent a systemic treatment (chemotherapy and/or targeted therapy) may be enrolled but will not be subject to data collection about BI-CAUSE - Study Protocol Version 1.0 Oct 18th, 2015 10 blood laboratory tests (with the exception of viral screening) and natural history, and will not be factored in the data analysis of prognostic factors. Performance status, life expectancy, tumour staging, tumour site (distal or hilar extrahepatic, intrahepatic), previous surgical resection, previous biliary stenting, previous radiotherapy are not part of inclusion/exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT02665494', 'briefTitle': 'Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors', 'organization': {'class': 'OTHER', 'fullName': "Fondazione del Piemonte per l'Oncologia"}, 'officialTitle': 'Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors', 'orgStudyIdInfo': {'id': 'BI-CAUSE'}}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'state': 'Bari', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Silvestris, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Tumori Giovanni Paolo II Bari - IRCCS', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Bologna', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': "Ospedale Sant'Orsola Malpighi", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '12100', 'city': 'Cuneo', 'state': 'Cuneo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Ricci, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliera S.Croce e Carle Cuneo', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'zip': '35128', 'city': 'Padua', 'state': 'Padova', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara Lonardi, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Oncologico Veneto - IRCCS', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '65124', 'city': 'Pescara', 'state': 'Pescara', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carlo Garufi, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Santo Spirito di Pescara', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '56126', 'city': 'Pisa', 'state': 'Pisa', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenzo Fornaro, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00128', 'city': 'Rome', 'state': 'Rome', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Santini, MD', 'role': 'CONTACT'}], 'facility': 'Policlinico Universitario Campus Bio-Medico', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00144', 'city': 'Rome', 'state': 'Rome', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Milella, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Nazionale Tumori Regina Elena', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '10127', 'city': 'Candiolo', 'state': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Celeste Cagnazzo, PhD', 'role': 'CONTACT'}], 'facility': "Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'zip': '10126', 'city': 'Turin', 'state': 'Turin', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Libero Ciuffreda, MD', 'role': 'CONTACT'}], 'facility': 'AOU Città della Salute e della Scienza di Torino - Ospedale Molinette', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '10128', 'city': 'Turin', 'state': 'Turin', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisa Sperti, MD', 'role': 'CONTACT'}], 'facility': 'AO Ordine Mauriziano di Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '33100', 'city': 'Udine', 'state': 'Udine', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Aprile, MD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria di Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'centralContacts': [{'name': 'Celeste Cagnazzo, PhD', 'role': 'CONTACT', 'email': 'celeste.cagnazzo@ircc.it', 'phone': '00390119933851'}], 'overallOfficials': [{'name': 'Francesco Leone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Candiolo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione del Piemonte per l'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}