Clinical trial NCT02665494: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholangiocarcinoma
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with diagnosis of all-stages cholangiocarcinoma, including rare and crossing-over histological types, and excluding gallbladder cancer and ampullary carcinoma

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.

Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo
state: Torino
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II Bari - IRCCS
city: Bologna
country: Italy
facility: Ospedale Sant'Orsola Malpighi
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S.Croce e Carle Cuneo
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - IRCCS
city: Pescara
country: Italy
facility: Ospedale Santo Spirito di Pescara
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Rome
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
city: Turin
country: Italy
facility: AO Ordine Mauriziano di Torino
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria di Udine
Study officials:
affiliation: IRCCS Candiolo
name: Francesco Leone, MD
role: PRINCIPAL_INVESTIGATOR
References: