Pharmacogenetic of Doxorubicin in HCC.

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06313047
• Other study ID #: Doxorubacin in HCC
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 30, 2023
• Est. primary completion date: December 15, 2023
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	King Abdullah bin Abdulaziz University Hospital	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
Rehab Werida	King Abdullah Bin Abdulaziz University Hospital, King Saud Bin Abdulaziz University for Health Sciences

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GSTP1	Genotyping	1 year
Primary	CYP2B6	Genotyping	1 year