FLNA in HCC Patients | NCT03081637

Studies
FLNA in HCC Patients

NCT03081637

Sponsor

University of Milan

Status

Completed

Last Update Posted

Jun 1, 2017Actual

Enrollment

115Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

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

May 2017

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

Jan 1, 2004Actual

Primary Completion Date

Dec 31, 2014Actual

Completion Date

Mar 2, 2017Actual

First Submitted Date

Mar 2, 2017

First Submission Date that Met QC Criteria

Mar 15, 2017

First Posted Date

Mar 16, 2017Actual

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

May 31, 2017

Last Update Posted Date

Jun 1, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Guido Torzilli, Professor of Surgery, Director Department of Hepatobiliary and General Surgery, University of MilanPrincipal Investigator

Lead Sponsor

University of MilanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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 risk of recurrence after hepatectomy for hepatocellular carcinoma (HCC) is very high. Having a predictive marker of early recurrence (ER) would be desirable to personalize the follow-up and possibly develop new targeted therapy. The aim of this study was to test the expression of Filamin A (FLNA) in a cohort of patients operated for HCC.

Detailed Description

A consecutive cohort of resected HCC patients will be analyzed. Several different prognostic factors, including FLNA expression, will be tested against the risk of ER. FLNA expression will be analyzed with immunohistochemistry in the intra-tumoral and extra-tumoral tissue compartments using a dedicated tissue microarray.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

115Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of expression of Filamin A (FLNA) in HCC specimens from patients resected for HCC.	The rate of expression of FLNA in HCC specimens will be measured using standard immunohistochemistry methodology on surgical specimens. Such expression rate will be correlated to several different clinical and pathological parameters.	2 years after surgery as a minimum follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The inclusion criteria were represented by the histological positivity for HCC with complete clinical, surgical, pathological, and follow-up data.

Exclusion Criteria:

Patients preoperatively treated with chemotherapy or trans-arterial therapy were excluded.
Similarly, patients operated for recurrent HCC or with non-radical surgery or with missing data were excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HCC patients submitted to hepatectomy at our unit in the above mentioned frame time.

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