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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02665494
• Other study ID #: BI-CAUSE
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2016
• Last updated: September 22, 2016
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2016
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Celeste Cagnazzo, PhD
• Phone: 00390119933851
• Email: celeste.cagnazzo[@]ircc.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholangiocarcinoma

Locations

Country	Name	City	State
Italy	Istituto Tumori Giovanni Paolo II Bari - IRCCS	Bari
Italy	Ospedale Sant'Orsola Malpighi	Bologna
Italy	Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo	Candiolo	Torino
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	Istituto Nazionale Tumori Regina Elena	Rome
Italy	Policlinico Universitario Campus Bio-Medico	Rome
Italy	AO Ordine Mauriziano di Torino	Turin
Italy	AOU Città della Salute e della Scienza di Torino - Ospedale Molinette	Turin
Italy	Azienda Ospedaliero-Universitaria di Udine	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No