NCT04220151

Brief Summary

Hepatocellular carcinoma (HCC) is the most common type of liver cancer, its survival rate ranks only second to lung cancer and it is a severe threat to human health. In Egypt, HCC constitutes a significant public health problem. Where it is responsible for 33.63% and 13.54% of all cancers in males and females respectively. It has a poor prognosis after discovery, which is usually at a late stage of disease. This had been strongly linked to the hepatitis C virus epidemic that affected around 10-15% of the Egyptian population during the last 3 decades, and was reported as the highest prevalence of HCV in the world. However, the pathophysiological mechanisms involved remain unclear. The occurrence of HCC is a complicated process involving multiple genes and steps. Imbalances in cellular signal transduction pathways, deficiencies in DNA repair regulating genes, activation of protooncogenes, inactivation of tumor suppressor genes and epigenetic modifications all promote the occurrence of liver cancer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

January 3, 2020

Last Update Submit

January 12, 2020

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaEpigeneticsDNA methylationDirect-acting antivirals

Outcome Measures

Primary Outcomes (1)

  • Percentages of methylation of DNA in patients with HCC

    Hypermethylation is known to be associated with decreased gene expression

    Baseline

Study Arms (3)

Hepatocellular carcinoma

Sixty patients with HCC

Genetic: DNA methylation

Hepatic cirrhosis

Thirty patients with hepatic cirrhosis

Genetic: DNA methylation

Healthy controls

Ten healthy controls.

Genetic: DNA methylation

Interventions

DNA methylationGENETIC

DNA methylation will be measured by real time polymerase chain reaction

Healthy controlsHepatic cirrhosisHepatocellular carcinoma

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hepatocellular carcinoma patients

You may qualify if:

  • HCC treated with DAAs drugs for chronic hepatitis C in Assiut University Hospital.

You may not qualify if:

  • Cases who started treatment for HCC like alcohol ablation or chemoembolization
  • Hepatitis B infection
  • Non-responder patients to DAAs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Aguilar-Medina M, Avendano-Felix M, Lizarraga-Verdugo E, Bermudez M, Romero-Quintana JG, Ramos-Payan R, Ruiz-Garcia E, Lopez-Camarillo C. SOX9 Stem-Cell Factor: Clinical and Functional Relevance in Cancer. J Oncol. 2019 Apr 1;2019:6754040. doi: 10.1155/2019/6754040. eCollection 2019.

    PMID: 31057614BACKGROUND

  • Cozma A, Fodor A, Vulturar R, Sitar-Taut AV, Orasan OH, Muresan F, Login C, Suharoschi R. DNA Methylation and Micro-RNAs: The Most Recent and Relevant Biomarkers in the Early Diagnosis of Hepatocellular Carcinoma. Medicina (Kaunas). 2019 Sep 19;55(9):607. doi: 10.3390/medicina55090607.

    PMID: 31546948BACKGROUND

  • Saleh DA, Amr S, Jillson IA, Wang JH, Crowell N, Loffredo CA. Preventing hepatocellular carcinoma in Egypt: results of a Pilot Health Education Intervention Study. BMC Res Notes. 2015 Aug 29;8:384. doi: 10.1186/s13104-015-1351-1.

    PMID: 26319021BACKGROUND

  • Perez S, Kaspi A, Domovitz T, Davidovich A, Lavi-Itzkovitz A, Meirson T, Alison Holmes J, Dai CY, Huang CF, Chung RT, Nimer A, El-Osta A, Yaari G, Stemmer SM, Yu ML, Haviv I, Gal-Tanamy M. Hepatitis C virus leaves an epigenetic signature post cure of infection by direct-acting antivirals. PLoS Genet. 2019 Jun 19;15(6):e1008181. doi: 10.1371/journal.pgen.1008181. eCollection 2019 Jun.

    PMID: 31216276BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

DNA Methylation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic Phenomena

Central Study Contacts

reham elmahdy

CONTACT

+201002714637reham.elmahdy@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 7, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share