NCT06313047

Brief Summary

The study included 81 HCC patients, both male and female. Prior to being assessed for eligibility, each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results. Every research participant take part in the experiment and provided written informed consent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration 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, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

March 9, 2024

Last Update Submit

March 27, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • GSTP1

    Genotyping

    1 year

  • CYP2B6

    Genotyping

    1 year

Study Arms (1)

HCC patients

Each of the patients was given Doxorubicin and followed up for one year.

Drug: Doxorubicin

Interventions

each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results.

Also known as: Dox
HCC patients

Eligibility Criteria

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

100 HCC patients, both male and female. Prior to being assessed for eligibility, each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results.

You may qualify if:

  • When diagnosing the patient with HCC, the guidelines provided by the American Association for the Study of Liver Diseases (AASLD) were adhered to.
  • Be above 20 years old.
  • Individuals with intact organs.
  • There is no cure for HCC in surgery, microwave treatment, or radiofrequency ablation.

You may not qualify if:

  • The patients refused to sign the formal consent.
  • Be more than 75 years old.
  • There is a notable case of portal vein thrombosis.
  • Spreads beyond the liver.
  • Encephalopathy of the liver.
  • Present sickness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdullah bin Abdulaziz University Hospital

Riyadh, Saudi Arabia

Location

Related Publications (1)

  • Shilbayeh SAR, Abd El-Baset OA, Alshabeeb MA, Alanizi AH, Khedr NF, Werida RH. The Influence of CYP2B6, GSTP1, and SLCO1B1 Star Allele-Predicted Phenotypes and CBR1 Genetic Variants on Effectiveness Outcomes in Patients With Hepatocellular Carcinoma Receiving Doxorubicin via Transarterial Chemoembolization. Pharmacol Res Perspect. 2025 Jun;13(3):e70114. doi: 10.1002/prp2.70114.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Sireen Shilbayeh, Prof.

    Princess Nourah Bint Abdul Rahman University

    STUDY CHAIR
  • Mohammad A. Alshabeeb

    King Saud Bin Abdulaziz University for Health Sciences

    STUDY DIRECTOR
  • Abdalrhman H Alanizi

    King Abdulaziz University

    PRINCIPAL INVESTIGATOR
  • Naglaa Khedr, Prof.

    Tanta University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 9, 2024

First Posted

March 15, 2024

Study Start

January 1, 2021

Primary Completion

December 15, 2023

Study Completion

December 30, 2023

Last Updated

March 28, 2024

Record last verified: 2024-03

Locations