East-West Hepatocellular Carcinoma Study Group | NCT01237132

Studies
East-West Hepatocellular Carcinoma Study Group

NCT01237132

Sponsor

University of Milan

Status

Completed

Last Update Posted

Nov 9, 2010Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Carcinoma, Hepatocellular

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 8, 2010

First Submission Date that Met QC Criteria

Nov 8, 2010

First Posted Date

Nov 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2010

Last Update Posted Date

Nov 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and European Associations for the Study of Liver Disease are based on the Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in patients with large, multinodular and macrovascular invasive disease. The aim of this study was to investigate the role of hepatic resection in a large retrospective multicentric cohort of patients resected for HCC regardless of the BCLC indications.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival of resected patients for HCC	The primary endpoint of the study was the overall survival of patients resected for HCC in any stage of the BCLC classification.

Secondary Outcomes

Measure	Description	Time Frame
Disease-free survival of resected patients for HCC	The secondary endpoint was the disease-free survival of patients resected for HCC among the BCLC stages.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of hepatocellular carcinoma
candidate to liver resection as a curative treatment

Exclusion Criteria:

uncertain diagnosis of hepatocellular carcinoma
uncertain follow-up data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients affected by HCC

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided