NCT04412161

Brief Summary

Retrospective data on 50 prospectively-collected HCC patients with beyond-Milan criteria with \>6cm tumors were analyzed. 5-year OS of 76.2% was found in patients with both AFP \<200 ng/ml and GGT \<104 IU/mL with tumors less than 10 cm diameter. Thus, GGT values add to AFP in patient prognosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2006

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

12.7 years

First QC Date

May 29, 2020

Last Update Submit

May 29, 2020

Conditions

Hepatocellular CarcinomaLiver Transplant Disorder

Keywords

Hepatic malignancyGGTliving donor

Outcome Measures

Primary Outcomes (1)

  • overall and disease free survivals

    to analyse the factors that effect the survivals

    five years follow up

Study Arms (1)

Extra-Malatya

Liver transplant patients with MTD\>6 cm of HCC

Procedure: Liver transplantation

Interventions

Liver transplantationPROCEDURE

Living donor liver transplantation

Extra-Malatya

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma

You may qualify if:

  • Liver transplant patients with maximum tumor diameter greater than 6 cm of hepatocellular carcinoma

You may not qualify if:

  • Early postoperative mortality (within 90 days)
  • Advanced stage tumors (explant patology revealed that tumor continues in the surgical cite such as positive lymph node metastases, macroscopic portal vein trombosis, diaphragmatic invasion, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FEBS, Assoc.Prof

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 2, 2020

Study Start

April 19, 2006

Primary Completion

January 1, 2019

Study Completion

December 1, 2019

Last Updated

June 2, 2020

Record last verified: 2020-05