Spots Global Cancer Trial Database for Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors
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Trial Identification
Brief Title: Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors
Official Title: Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors
Study ID: NCT02665494
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo, Candiolo, Torino, Italy
Istituto Tumori Giovanni Paolo II Bari - IRCCS, Bari, , Italy
Ospedale Sant'Orsola Malpighi, Bologna, , Italy
Azienda Ospedaliera S.Croce e Carle Cuneo, Cuneo, , Italy
Istituto Oncologico Veneto - IRCCS, Padova, , Italy
Ospedale Santo Spirito di Pescara, Pescara, , Italy
Azienda Ospedaliero-Universitaria Pisana, Pisa, , Italy
Policlinico Universitario Campus Bio-Medico, Rome, , Italy
Istituto Nazionale Tumori Regina Elena, Rome, , Italy
AOU Città della Salute e della Scienza di Torino - Ospedale Molinette, Turin, , Italy
AO Ordine Mauriziano di Torino, Turin, , Italy
Azienda Ospedaliero-Universitaria di Udine, Udine, , Italy
Contact Details
Name: Francesco Leone, MD
Affiliation: IRCCS Candiolo
Role: PRINCIPAL_INVESTIGATOR
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