Pharmacogenetic of Doxorubicin in HCC.

NCT ID: NCT06313047

Last Updated: 2024-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HCC patients

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

Doxorubicin

Intervention Type DRUG

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

Interventions

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Doxorubicin

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

Intervention Type DRUG

Other Intervention Names

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Dox

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Saud Bin Abdulaziz University for Health Sciences

OTHER

Sponsor Role collaborator

King Abdulaziz University

OTHER

Sponsor Role collaborator

Rehab Werida

OTHER

Sponsor Role lead

Responsible Party

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Rehab Werida

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sireen Shilbayeh, Prof.

Role: STUDY_CHAIR

Princess Nourah Bint Abdul Rahman University

Mohammad A. Alshabeeb

Role: STUDY_DIRECTOR

King Saud Bin Abdulaziz University for Health Sciences

Abdalrhman H Alanizi

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

Naglaa Khedr, Prof.

Role: STUDY_DIRECTOR

Tanta University

Locations

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King Abdullah bin Abdulaziz University Hospital

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 40405401 (View on PubMed)

Other Identifiers

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Doxorubacin in HCC

Identifier Type: -

Identifier Source: org_study_id

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