Hepatocarcinoma Recurrence on the Liver Study - Part2

NCT04053231 | Not Yet Recruiting DMC

• 1 other identifier: HERCOLES-2
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Liver Cancer; Surgery; Recurrence Tumor; Cirrhosis

Keywords

liver; hcc; hepatocarcinoma; surgery; redo surgery; recurrence; cirrhosis

Outcome Measures

Primary Outcomes (2)

• Disease-free-Survival

  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.

  15 years of follow-up

• Overall Survival

  The time from surgery to death measured in months. If no event, patients will be censored at the last available follow-up.

  15 years of follow-up

Secondary Outcomes (2)

• Localization of the recurrence

  15 years of follow-up

• Number of redo-surgery

  15 years

Interventions

liver resection OTHER

all type of liver surgical procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients treated by surgery for HCC

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (19)

Chirurgia Rubino - Policlinico di Bari

Bari, Italy

Location

Ospedale Maggiore- AUSL

Bologna, Italy

Location

Chirurgia Generale Bolzano

Bolzano, Italy

Location

Fondazione Poliambulanza - Istituto Ospedaliero

Brescia, Italy

Location

Spedali Civili

Brescia, Italy

Location

Chirurgia Generale Ospedale Pierantoni - Morgagni

Forlì, Italy

Location

Ospedale A. Manzoni - ASST Lecco

Lecco, Italy

Location

ASST-Mantova

Mantova, Italy

Location

Asst-Fbf-Sacco Polo Universitario H. Sacco Chirurgia 2

Milan, Italy

Location

IRCCS Osp. San Raffaele, Divisione Chirurgia Generale Epatobiliare

Milan, Italy

Location

Policlinico di Monza

Monza, Italy

Location

UOS Chirurgia Oncologica ad inidirzzo epato-bilio-pancreatico

Parma, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Rome, Italy

Location

Irccs Istituto Nazionale Tumori Regina Elena

Rome, Italy

Location

Humanitas Research Hospital

Rozzano, Italy

Location

Ospedale San Paolo

Savona, Italy

Location

Chirurgia 4 Ospedale Ca'Foncello

Treviso, Italy

Location

Chirurgia Epatobiliare Università degli studi di Verona

Verona, Italy

Location

Related Links

• All the informations and protocol are available at the website

MeSH Terms

Conditions

Liver Neoplasms; Recurrence; Fibrosis; Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Fabrizio Romano, MD

  University of Milan-Bicocca

  PRINCIPAL INVESTIGATOR

• Simone Famularo, MD

  University of Milan Bicocca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Famularo, MD

CONTACT

+393296533353; simone.famularo@gmail.com

Cristina Ciulli, MD

CONTACT

+393896460025; c.ciulli@campus.unimib.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: July 6, 2019
• First Posted: August 12, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2022
• Study Completion (Estimated): May 1, 2034
• Last Updated: August 12, 2019

Record last verified: 2019-08

Locations

IT (19)