Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors

• Conditions: Cholangiocarcinoma

• Registration Number: NCT02665494
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-24
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-27
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• voluntary, written, dated and signed informed consent;
• age ≥ 18 years;
• histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms). Neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma.

Exclusion Criteria

• Dementia or altered mental status leading to inability to understand or render the informed consent.
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	36 months

Trial Locations

Locations (12)

Azienda Ospedaliera S.Croce e Carle Cuneo; 🇮🇹 Cuneo, Italy

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

Istituto Oncologico Veneto - IRCCS; 🇮🇹 Padova, Italy

Ospedale Santo Spirito di Pescara; 🇮🇹 Pescara, Italy

Policlinico Universitario Campus Bio-Medico; 🇮🇹 Rome, Italy

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, 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