NCT03081637

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

11 years

First QC Date

March 2, 2017

Last Update Submit

May 31, 2017

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgical specimen from patients resected for HCC.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, Director Department of Hepatobiliary and General Surgery

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 16, 2017

Study Start

January 1, 2004

Primary Completion

December 31, 2014

Study Completion

March 2, 2017

Last Updated

June 1, 2017

Record last verified: 2017-05