NCT01520779

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

January 26, 2012

Last Update Submit

September 29, 2013

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular cacinomaRadiofrequancy ablationIntrahepatic recurrence

Outcome Measures

Primary Outcomes (1)

  • Recurrence of hepatocellular carcinoma

    1 year

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical medicine department

Cairo, Egypt

Location

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
Lecturer of tropical medicine , Ain Shams university

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 30, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

EG(1)