Pharmacogenetic of Doxorubicin in HCC.

March 27, 2024 updated by: Rehab Werida

Pharmacogenetic of Doxorubicin in Patients With Hepatocellular Carcinoma: A Prospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients had their baseline viral indicators for HBV and HCV evaluated. Additionally, blood samples were taken for genotyping. All patients underwent evaluations of their kidney, liver, and alpha fetoprotein (AFP) functions, as well as their complete blood count (CBC), at both the baseline and follow-up appointments. To evaluate the efficacy of TACE, triple pelvic abdominal CT scans were performed both prior to and one month later. Using triphasic pelviabdominal CT, patients who achieved complete response (CR) were monitored for up to 13 months following chemotherapy in order to identify recurrence. Follow-up appointments were planned to identify patients responces or any negative effects.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Abdullah bin Abdulaziz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC patients
Each of the patients was given Doxorubicin and followed up for one year.
Drug: Doxorubicin
each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results.
Other Names:
  • Dox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GSTP1
Time Frame: 1 year
Genotyping
1 year
CYP2B6
Time Frame: 1 year
Genotyping
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehab Werida

Collaborators

King Saud Bin Abdulaziz University for Health Sciences
King Abdullah Bin Abdulaziz University Hospital

Investigators

  • Study Director: Naglaa Khedr, Prof., Tanta University
  • Study Director: Mohammad A. Alshabeeb, King Saud Bin Abdulaziz University for Health Sciences
  • Principal Investigator: Abdalrhman H Alanizi, King Abdullah bin Abdulaziz University Hospital
  • Study Chair: Sireen Shilbayeh, Prof., Princess Nourah Bint Abdul Rahman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

March 9, 2024

First Submitted That Met QC Criteria

March 9, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doxorubacin in HCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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