Ireland
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Starting soon Observational

Hepatocarcinoma Recurrence on the Liver Study - Part2

NCT04053231 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2019-09
Last updated
2019-08-12

Condition(s) studied

Liver CancerSurgeryRecurrence TumorCirrhosis

Investigational drug(s) / intervention(s)

liver resection

liver resection: all type of liver surgical procedures

Study summary

Rationale for the trial. To evaluate the impact of surgery on hepatocarcinoma recurrence. Thus, to evaluate the impact of different clinical, radiological, histopathological variables on recurrence after surgical treatment. The nature of this study will allow to observe, over time, the distribution of the considered collection variables, allowing a strictly observational monitoring of possible associations able to suggest models or interpretations, which can then be the basis for the construction of prospective and randomized studies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * No age limit. * Hepatocarcinoma diagnosis confirmed at histological specimen * Every single patients with first HCC diagnosis or with a recurrence/persistence disease evaluated and treated with surgery at the participating center. * the assessment for patient enrollment must have been performed starting from 02/02/2019. Exclusion Criteria: * Surgery as a downstaging therapy for transplant * Patients treated with surgery in case of not-curative intent (palliation, best supportive care, etc). * Histopathological specimen of combined liver primary neoplasms (e.g. "hepatocholangiocarcinoma''). * Patients with other tumors in the previous past.

Primary outcome measure(s)

  • Disease-free-Survival — 15 years of follow-up
    Disease Free Survival: the time between surgery and event of recurrence or death measured in months. If no event, patients will be censored at the last available follow-up date.
  • Overall Survival — 15 years of follow-up
    The time from surgery to death measured in months. If no event, patients will be censored at the last available follow-up.

Trial sites (19)

FacilityCityRegionStatus
Chirurgia Rubino - Policlinico di Bari Bari Italy
Ospedale Maggiore- AUSL Bologna Italy
Chirurgia Generale Bolzano Bolzano Italy
Fondazione Poliambulanza - Istituto Ospedaliero Brescia Italy
Spedali Civili Brescia Italy
Chirurgia Generale Ospedale Pierantoni - Morgagni Forlì Italy
Ospedale A. Manzoni - ASST Lecco Lecco Italy
ASST-Mantova Mantua Italy
Asst-Fbf-Sacco Polo Universitario H. Sacco Chirurgia 2 Milan Italy
IRCCS Osp. San Raffaele, Divisione Chirurgia Generale Epatobiliare Milan Italy
Policlinico di Monza Monza Italy
UOS Chirurgia Oncologica ad inidirzzo epato-bilio-pancreatico Parma Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Fondazione Policlinico Universitario A. Gemelli, IRCCS Rome Italy
Irccs Istituto Nazionale Tumori Regina Elena Rome Italy
Humanitas Research Hospital Rozzano Italy
Ospedale San Paolo Savona Italy
Chirurgia 4 Ospedale Ca'Foncello Treviso Italy
Chirurgia Epatobiliare Università degli studi di Verona Verona Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04053231 on ClinicalTrials.gov ↗ ← All trials in Italy