Recurrence of Hepatocellular Carcinoma | NCT01520779

Studies
Recurrence of Hepatocellular Carcinoma

NCT01520779

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Oct 1, 2013Estimated

Enrollment

99Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

Not provided

Countries

Egypt

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

Sep 2013

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 2012

Primary Completion Date

Nov 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 26, 2012

First Submission Date that Met QC Criteria

Jan 26, 2012

First Posted Date

Jan 30, 2012Estimated

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

Sep 29, 2013

Last Update Posted Date

Oct 1, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Iman Fawzy Montasser, Lecturer of tropical medicine , Ain Shams university, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

analysis of the risk factors of intra-hepatic distant recurrence (IDR) of hepatocellular carcinoma within 1 year after radiofrequency ablation.

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

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

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with recurrence		Hepatocellular carcinoma patients with intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation
Patients with no recurrence		Hepatocellular carcinoma with no intra-hepatic or distant recurrence of hepatocellular carcinoma within 1 year after radiofrequency ablation

Interventions

Not provided

Measure	Description	Time Frame
Recurrence of hepatocellular carcinoma		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Proved diagnosis of HCC according to AASLD practice guidelines (Bruix and Sherman, 2005).
Patients underwent RFA for HCC with BCLC (The Barcelona-Clinic- Liver-Cancer staging system) stage A (Bruix and Sherman, 2005) with no eligibility or ability to do transplantation or resection.
Patients should be followed-up for more than 12 months to exclude early recurrence i.e. recurrence within 1 year.
Patients with INR < 1.5 or prothrombin concentration > 50%.
Platelet count > 50000 cell/mm3.

Exclusion Criteria:

Presence of extra-hepatic metastasis or gross vascular invasion.
Child class C patients.
Follow up period of less than 12 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with hepatocellular carcinoma (HCC) who underwent radiofrequency ablation (RFA) from 1/2006 till 12/2010in Tropical medicine department and hepatocellular carcinoma clinic, Ain Shams university

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tropical medicine department		Cairo			Egypt

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