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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02665494

Enrollment

500

Registered

2016-01-27

Start date

2016-01-31

Completion date

2019-12-31

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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

Countries

Italy

Contacts

Primary ContactCeleste Cagnazzo, PhD

celeste.cagnazzo@ircc.it00390119933851

Outcome results