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CompletedNCT06313047Updated Mar 28, 2024

Pharmacogenetic of Doxorubicin in HCC.

An observational study in Hepatocellular Carcinoma, sponsored by Rehab Werida. Completed at 1 site in Saudi Arabia. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Rehab Werida · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
81
Ages
20 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 81 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Rehab Werida is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
81 participants (actual)
Patient registry
No

Groups and cohorts

  • HCC patients

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

    Drug: Doxorubicin

Interventions

  • DrugDoxorubicin

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

    Also known as: Dox

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What researchers measure

Primary outcomes

  1. GSTP1

    Genotyping

    Time frame: 1 year

  2. CYP2B6

    Genotyping

    Time frame: 1 year

07

Study locations

1 site
  • King Abdullah bin Abdulaziz University Hospital
    Riyadh, Saudi Arabia
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06313047
Lead sponsor
Rehab Werida
Collaborators
King Saud Bin Abdulaziz University for Health Sciences, King Abdullah Bin Abdulaziz University Hospital
Responsible party
Rehab Werida (Associate Professor, Damanhour University) — Sponsor-investigator
First posted
Mar 15, 2024
Start date
Jan 1, 2021
Primary completion
Dec 15, 2023
Completion
Dec 30, 2023
Last update
Mar 28, 2024

Study contacts

Sireen Shilbayeh, Prof.
study chair · Princess Nourah Bint Abdul Rahman University
Mohammad A. Alshabeeb
study director · King Saud Bin Abdulaziz University for Health Sciences
Abdalrhman H Alanizi
principal investigator · King Abdullah Bin Abdulaziz University Hospital
Naglaa Khedr, Prof.
study director · Tanta University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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