Hepatocellular CarcinomaNCT06313047
Pharmacogenetic of Doxorubicin in HCC.
An observational study of Hepatocellular Carcinoma, run by Rehab Werida at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Doxorubicin
- How many people
- 81 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2021to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- When diagnosing the patient with HCC, the guidelines provided by the American Association for the Study of Liver Diseases (AASLD) were adhered to.
- Be above 20 years old.
- Individuals with intact organs.
- There is no cure for HCC in surgery, microwave treatment, or radiofrequency ablation.
Who cannot join
- The patients refused to sign the formal consent.
- Be more than 75 years old.
- There is a notable case of portal vein thrombosis.
- Spreads beyond the liver.
- Encephalopathy of the liver.
- Present sickness.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdullah bin Abdulaziz University Hospital
Riyadh
About this study
Official title: 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.
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Doxorubicin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called Dox
each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results.
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | Each of the patients was given Doxorubicin and followed up for one year. Receives: Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSTP1
Genotyping
Measured: 1 year
CYP2B6
Genotyping
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jan 2021
- Primary completion15 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud Bin Abdulaziz University for Health Sciences, King Abdulaziz University
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Sireen Shilbayeh, Prof., Study chair, Princess Nourah Bint Abdul Rahman UniversityMohammad A. Alshabeeb, Study director, King Saud Bin Abdulaziz University for Health SciencesAbdalrhman H Alanizi, Principal investigator, King Abdulaziz UniversityNaglaa Khedr, Prof., Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313047
- Sponsor's protocol ID
- Doxorubacin in HCC
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40405401
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic of Doxorubicin in Patients With Hepatocellular Carcinoma: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06313047
- Acronym / sponsor ID
- Doxorubacin in HCC
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Collaborators
- King Saud Bin Abdulaziz University for Health Sciences, King Abdulaziz University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients | – | Drug: DoxorubicinEach of the patients was given Doxorubicin and followed up for one year. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- When diagnosing the patient with HCC, the guidelines provided by the American Association for the Study of Liver Diseases (AASLD) were adhered to.
- Be above 20 years old.
- Individuals with intact organs.
- There is no cure for HCC in surgery, microwave treatment, or radiofrequency ablation.
Key exclusion criteria (6 listed)
- The patients refused to sign the formal consent.
- Be more than 75 years old.
- There is a notable case of portal vein thrombosis.
- Spreads beyond the liver.
- Encephalopathy of the liver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxorubicinAlso: Doxeach recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results. | Drug | HCC patients |
Primary outcome
GSTP1
Time frame: 1 year
Genotyping
CYP2B6
Time frame: 1 year
Genotyping
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 40405401Shilbayeh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Rehab Werida at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GSTP1 (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06313047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.