NCT05568576

Brief Summary

Although hepatitis C virus (HCV) infection remains one of the main causes of hepatocellular carcinoma (HCC) worldwide, metabolic syndrome, with its increase in prevalence, has become an important and significant risk factor for HCC

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 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, 2015

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

8 years

First QC Date

October 2, 2022

Last Update Submit

May 4, 2023

Conditions

Keywords

Metabolic syndrome, survival, hepatocellular carcinom

Outcome Measures

Primary Outcomes (1)

  • Survival

    assess frequency long term survival after resection

    between two and five years

Study Arms (1)

patients with HCC underwent resection

patients with HCC underwent resection

Eligibility Criteria

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

All patients with HCC secondary to HCV infection underwent hepatic resection

You may qualify if:

  • \- All patients with HCC secondary to HCV infection underwent hepatic resection

You may not qualify if:

  • HBV patients other modalities of therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Mohammed Abu-Elfatth

Asyut, 71515, Egypt

Location

Related Publications (2)

  • Tan Y, Zhang X, Zhang W, Tang L, Yang H, Yan K, Jiang L, Yang J, Li C, Yang J, Wen T, Tang H, Yan L. The Influence of Metabolic Syndrome on the Risk of Hepatocellular Carcinoma in Patients with Chronic Hepatitis B Infection in Mainland China. Cancer Epidemiol Biomarkers Prev. 2019 Dec;28(12):2038-2046. doi: 10.1158/1055-9965.EPI-19-0303. Epub 2019 Sep 18.

  • Rashed WM, Kandeil MAM, Mahmoud MO, Ezzat S. Hepatocellular Carcinoma (HCC) in Egypt: A comprehensive overview. J Egypt Natl Canc Inst. 2020 Jan 16;32(1):5. doi: 10.1186/s43046-020-0016-x.

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ahmed Shwakt

    Assiut University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical Medicine and Gastroenterology

Study Record Dates

First Submitted

October 2, 2022

First Posted

October 5, 2022

Study Start

January 1, 2015

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations