Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors
1 other identifier
observational
500
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 24, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedSeptember 23, 2016
September 1, 2016
3.9 years
January 24, 2016
September 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
patients with diagnosis of all-stages cholangiocarcinoma, including rare and crossing-over histological types, and excluding gallbladder cancer and ampullary carcinoma
You may qualify if:
- 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.
You may not qualify if:
- Dementia or altered mental status leading to inability to understand or render the informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Istituto Tumori Giovanni Paolo II Bari - IRCCS
Bari, Bari, 70124, Italy
Ospedale Sant'Orsola Malpighi
Bologna, Bologna, 40138, Italy
Azienda Ospedaliera S.Croce e Carle Cuneo
Cuneo, Cuneo, 12100, Italy
Istituto Oncologico Veneto - IRCCS
Padua, Padova, 35128, Italy
Ospedale Santo Spirito di Pescara
Pescara, Pescara, 65124, Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, Pisa, 56126, Italy
Policlinico Universitario Campus Bio-Medico
Rome, Rome, 00128, Italy
Istituto Nazionale Tumori Regina Elena
Rome, Rome, 00144, Italy
Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo
Candiolo, Torino, 10127, Italy
AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
Turin, Turin, 10126, Italy
AO Ordine Mauriziano di Torino
Turin, Turin, 10128, Italy
Azienda Ospedaliero-Universitaria di Udine
Udine, Udine, 33100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Leone, MD
IRCCS Candiolo
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2016
First Posted
January 27, 2016
Study Start
January 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
September 23, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share