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Trial record 4 of 160 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02665494
Recruitment Status : Recruiting
First Posted : January 27, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Cholangiocarcinoma

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 Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019





Primary Outcome Measures :
  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 [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665494


Contacts
Contact: Celeste Cagnazzo, PhD 00390119933851 celeste.cagnazzo@ircc.it

Locations
Italy
Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo Recruiting
Candiolo, Torino, Italy, 10127
Contact: Celeste Cagnazzo, PhD         
Istituto Tumori Giovanni Paolo II Bari - IRCCS Not yet recruiting
Bari, Italy, 70124
Contact: Nicola Silvestris, MD         
Ospedale Sant'Orsola Malpighi Active, not recruiting
Bologna, Italy, 40138
Azienda Ospedaliera S.Croce e Carle Cuneo Not yet recruiting
Cuneo, Italy, 12100
Contact: Vincenzo Ricci, MD         
Istituto Oncologico Veneto - IRCCS Not yet recruiting
Padova, Italy, 35128
Contact: Sara Lonardi, MD         
Ospedale Santo Spirito di Pescara Not yet recruiting
Pescara, Italy, 65124
Contact: Carlo Garufi, MD         
Azienda Ospedaliero-Universitaria Pisana Not yet recruiting
Pisa, Italy, 56126
Contact: Lorenzo Fornaro, MD         
Policlinico Universitario Campus Bio-Medico Not yet recruiting
Rome, Italy, 00128
Contact: Daniele Santini, MD         
Istituto Nazionale Tumori Regina Elena Not yet recruiting
Rome, Italy, 00144
Contact: Michele Milella, MD         
AOU Città della Salute e della Scienza di Torino - Ospedale Molinette Not yet recruiting
Turin, Italy, 10126
Contact: Libero Ciuffreda, MD         
AO Ordine Mauriziano di Torino Not yet recruiting
Turin, Italy, 10128
Contact: Elisa Sperti, MD         
Azienda Ospedaliero-Universitaria di Udine Not yet recruiting
Udine, Italy, 33100
Contact: Giuseppe Aprile, MD         
Sponsors and Collaborators
Fondazione del Piemonte per l'Oncologia
Investigators
Principal Investigator: Francesco Leone, MD IRCCS Candiolo

Responsible Party: Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier: NCT02665494     History of Changes
Other Study ID Numbers: BI-CAUSE
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms