Clinical trial NCT06313047: Pharmacogenetic of Doxorubicin in HCC.
Official title: Pharmacogenetic of Doxorubicin in Patients With Hepatocellular Carcinoma: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: King Saud Bin Abdulaziz University for Health Sciences
name: King Abdullah Bin Abdulaziz University Hospital
First posted: 2024-03-15
Enrollment: 81
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: GSTP1
timeFrame: 1 year
measure: CYP2B6
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdullah bin Abdulaziz University Hospital
Study officials:
affiliation: Princess Nourah Bint Abdul Rahman University
name: Sireen Shilbayeh, Prof.
role: STUDY_CHAIR
affiliation: King Saud Bin Abdulaziz University for Health Sciences
name: Mohammad A. Alshabeeb
role: STUDY_DIRECTOR
affiliation: King Abdullah Bin Abdulaziz University Hospital
name: Abdalrhman H Alanizi
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University
name: Naglaa Khedr, Prof.
role: STUDY_DIRECTOR
References: