Hepatocellular CarcinomaNCT05291338
Pharmacogenetic Study in Hepatocellular Carcinoma Patients.
An observational study of Hepatocellular Carcinoma, run by Rehab Werida at 1 site in Egypt.
Trial summary
evaluate the prognostic value of genetic polymorphisms in HCC Egyptian patients undergoing TACE using lipiodol and doxorubicin. 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 and Lipiodol
- How many people
- 107 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Apr 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: Egyptian HCC patients on doxorubicin and lipiodol treatment
Who may be able to join
- Eligible patients should fulfill the following criteria:
- A diagnosed HCC patient.
- Age ≥20 years.
- Patients with adequate organ function.
- HCC not eligible for curative measures (radiofrequency, microwave and surgery).
Who cannot join
- Patient will be excluded for any of the following:
- Patients refused to sign the written consent.
- Age > 75 years.
- The presence of major portal vein thrombosis.
- Extrahepatic metastases.
- Hepatic encephalopathy.
Show all 12Show fewer
- Current infection.
- Gastrointestinal bleeding within a month.
- Uncontrolled ascites.
- Serum bilirubin > 3.0 mg/dl, serum albumin < 2.8 g/dl, serum creatinine concentration > 1.5 mg/dl, white blood cell counts < 3,000/mm3 and platelet counts < 30,000/mm3.
- Patients with other types of malignancy, advanced organ failure, and advanced medical co-morbidity.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University hepatoma group, EL Demerdash Hospital, Cairo, Egypt.
Cairo
About this study
Official title: Pharmacogenetic Study in Hepatocellular Carcinoma Patients Underwent TACE
evaluate the prognostic value of genetic polymorphisms in HCC Egyptian patients undergoing TACE using lipiodol and doxorubicin.
Read the detailed description
Research Objectives This study aims to determine the predictive effect of ANG-2 and IL28B genetic polymorphisms in safety and efficacy of doxorubicin and lipiodol used for the treatment of Egyptian HCC patients. Moreover, this study will determine the association between genetic polymorphisms of ANG-2 and IL28B with HCC severity.
Patients \& Methods Study design Our study is a prospective study for HCC patients undergoing TACE of doxorubicin and lipiodol.
Sample Size Based on previous published incidence of gene it will be at least 116 patients. Efficacy and Safety
- Target lesions response will be measured according to modified Response Evaluation Criteria in Solid Tumors (RECIST) to (15): Complete response, Partial response, Progressive disease and Stable disease.
- Repeated TACE sessions will be planned individually based on the tumor response to the treatment protocol.
- Follow up will be performed for detection of tumor size using triphasic CT scan as a measure of efficacy. Moreover, all patients will be reevaluated for CBC, liver and kidney functions, in the follow up visit, to detect incidence of any adverse effects.
- Patients will be asked for any side effects such as (myelosuppression, anorexia, nausea, vomiting, and/or alopecia).
- Patients will be followed for progression-free survival after receiving TACE.
Method \& Proposal Steps
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- Patients will be recruited from Ain Shams University hepatoma group, EL Demerdash Hospital, Cairo, Egypt.
- At baseline and follow up visits after TACE, all patients will be assessed for complete blood count (CBC), kidney function, liver function, liver enzymes, alpha fetoprotein (AFP) and viral markers. Moreover, triphasic pelviabdominal CT will be performed before and after TACE.
- Serum samples will be collected for ANG-2 and IL28B genotyping.
- Genetic polymorphisms of ANG-2 and IL28B will be detected by real time polymerase chain reaction (RT-PCR).
- Five mls of whole blood will be collected then separation of plasma will be performed.
- Extraction of genomic DNA from blood samples by DNA extraction kit.
- DNA qualification will be performed by Nano drop.
- Genotyping will be done by allelic discrimination using Taqman assays specific for each polymorphism.
- Assays will be done according to manufacturer protocol using real time PCR machine.
- All patients will receive lipiodol and doxorubicin during TACE. Doxorubicin dose will differ among patients according to tumor size, patient condition, patient's laboratory data and presence of hepatic arteriovenous fistula.
- Appropriate statistical tests will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Doxorubicin, Lipiodol
- Keywords
- ANG-2, IL28B, genetic polymorphisms
- 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 Adriamycin
no optimal dosage of doxorubicin in TACE procedures (ranging from 30 to 75 mg/m2 up to a maximum of 150 mg/m2 ) according to tumor size
LipiodolDrug
Also called ethiodized oil
Lipiodol dose should be over 5 ml if tumor diameter is less than 5 cm, and the maximum dose will be 10 ml when the tumor develops to more than 5 cm in diameter.
| Study group | Role | What they receive |
|---|---|---|
| HCC patients | 116 hepatocellular carcinoma patients underwent TACE Receives: Drug: Doxorubicin; Drug: Lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiopoietin (ANG-2) rs55633437.
Gene
Measured: 1 month
Interleukin 28 B (IL28B) rs12979860.
Gene
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Jan 2022
- Primary completion31 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass Prof., Study director, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291338
- Sponsor's protocol ID
- genetic in hepatic cancer
- Status last verified
- Jul 2023
- First submitted
- 12 Mar 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marisi G, Petracci E, Raimondi F, Faloppi L, Foschi FG, Lauletta G, Iavarone M, Canale M, Valgiusti M, Neri LM, Ulivi P, Orsi G, Rovesti G, Vukotic R, Conti F, Cucchetti A, Ercolani G, Andrikou K, Cascinu S, Scartozzi M, Casadei-Gardini A. ANGPT2 and NOS3 Polymorphisms and Clinical Outcome in Advanced Hepatocellular Carcinoma Patients Receiving Sorafenib. Cancers (Basel). 2019 Jul 20;11(7):1023. doi: 10.3390/cancers11071023.
PubMed 31330833Rashed WM, Kandeil MAM, Mahmoud MO, Ezzat S. Hepatocellular Carcinoma (HCC) in Egypt: A comprehensive overview. J Egypt Natl Canc Inst. 2020 Jan 16;32(1):5. doi: 10.1186/s43046-020-0016-x.
PubMed 32372179Werida RH, Abd El Baset OA, Askar S, El-Mohamdy M, Omran GA, Hagag RS. Efficacy of doxorubicin and lipiodol therapy by trans-arterial chemoembolization in hepatocellular carcinoma Egyptian patients and relation to genetic polymorphisms. Expert Rev Anticancer Ther. 2024 Oct;24(10):1009-1020. doi: 10.1080/14737140.2024.2391364. Epub 2024 Aug 21.
PubMed 39138591
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Study in Hepatocellular Carcinoma Patients Underwent TACE
- ClinicalTrials.gov ID
- NCT05291338
- Acronym / sponsor ID
- genetic in hepatic cancer
- Conditions
- Hepatocellular Carcinoma
- Keywords
- ANG-2, IL28B, genetic polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 22 Mar 2022 (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.
evaluate the prognostic value of genetic polymorphisms in HCC Egyptian patients undergoing TACE using lipiodol and doxorubicin.
Detailed description
Research Objectives This study aims to determine the predictive effect of ANG-2 and IL28B genetic polymorphisms in safety and efficacy of doxorubicin and lipiodol used for the treatment of Egyptian HCC patients. Moreover, this study will determine the association between genetic polymorphisms of ANG-2 and IL28B with HCC severity.
Patients \& Methods Study design Our study is a prospective study for HCC patients undergoing TACE of doxorubicin and lipiodol.
Sample Size Based on previous published incidence of gene it will be at least 116 patients. Efficacy and Safety
- Target lesions response will be measured according to modified Response Evaluation Criteria in Solid Tumors (RECIST) to (15): Complete response, Partial response, Progressive disease and Stable disease.
- Repeated TACE sessions will be planned individually based on the tumor response to the treatment protocol.
- Follow up will be performed for detection of tumor size using triphasic CT scan as a measure of efficacy. Moreover, all patients will be reevaluated for CBC, liver and kidney functions, in the follow up visit, to detect incidence of any adverse effects.
- Patients will be asked for any side effects such as (myelosuppression, anorexia, nausea, vomiting, and/or alopecia).
- Patients will be followed for progression-free survival after receiving TACE.
Method \& Proposal Steps
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- Patients will be recruited from Ain Shams University hepatoma group, EL Demerdash Hospital, Cairo, Egypt.
- At baseline and follow up visits after TACE, all patients will be assessed for complete blood count (CBC), kidney function, liver function, liver enzymes, alpha fetoprotein (AFP) and viral markers. Moreover, triphasic pelviabdominal CT will be performed before and after TACE.
- Serum samples will be collected for ANG-2 and IL28B genotyping.
- Genetic polymorphisms of ANG-2 and IL28B will be detected by real time polymerase chain reaction (RT-PCR).
- Five mls of whole blood will be collected then separation of plasma will be performed.
- Extraction of genomic DNA from blood samples by DNA extraction kit.
- DNA qualification will be performed by Nano drop.
- Genotyping will be done by allelic discrimination using Taqman assays specific for each polymorphism.
- Assays will be done according to manufacturer protocol using real time PCR machine.
- All patients will receive lipiodol and doxorubicin during TACE. Doxorubicin dose will differ among patients according to tumor size, patient condition, patient's laboratory data and presence of hepatic arteriovenous fistula.
- Appropriate statistical tests will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients | – | Drug: Doxorubicin, Drug: Lipiodol116 hepatocellular carcinoma patients underwent TACE |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Egyptian HCC patients on doxorubicin and lipiodol treatment
Key inclusion criteria (5 listed)
- Eligible patients should fulfill the following criteria:
Key exclusion criteria (12 listed)
- Patient will be excluded for any of the following:
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: Adriamycinno optimal dosage of doxorubicin in TACE procedures (ranging from 30 to 75 mg/m2 up to a maximum of 150 mg/m2 ) according to tumor size | Drug | HCC patients |
| LipiodolAlso: ethiodized oilLipiodol dose should be over 5 ml if tumor diameter is less than 5 cm, and the maximum dose will be 10 ml when the tumor develops to more than 5 cm in diameter. | Drug | HCC patients |
Primary outcome
Angiopoietin (ANG-2) rs55633437.
Time frame: 1 month
Gene
Interleukin 28 B (IL28B) rs12979860.
Time frame: 1 month
Gene
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 Jul 2023.
- Background: PubMed 31330833Marisi G, Petracci E, Raimondi F, Faloppi L, Foschi FG, Lauletta G, Iavarone M, Canale M, Valgiusti M, Neri LM, Ulivi P, Orsi G, Rovesti G, Vukotic R, Conti F, Cucchetti A, Ercolani G, Andrikou K, Cascinu S, Scartozzi M, Casadei-Gardini A. ANGPT2 and NOS3 Polymorphisms and Clinical Outcome in Advanced Hepatocellular Carcinoma Patients Receiving Sorafenib. Cancers (Basel). 2019 Jul 20;11(7):1023. doi: 10.3390/cancers11071023.
- Background: PubMed 32372179Rashed WM, Kandeil MAM, Mahmoud MO, Ezzat S. Hepatocellular Carcinoma (HCC) in Egypt: A comprehensive overview. J Egypt Natl Canc Inst. 2020 Jan 16;32(1):5. doi: 10.1186/s43046-020-0016-x.
- Derived from this study: PubMed 39138591Werida RH, Abd El Baset OA, Askar S, El-Mohamdy M, Omran GA, Hagag RS. Efficacy of doxorubicin and lipiodol therapy by trans-arterial chemoembolization in hepatocellular carcinoma Egyptian patients and relation to genetic polymorphisms. Expert Rev Anticancer Ther. 2024 Oct;24(10):1009-1020. doi: 10.1080/14737140.2024.2391364. Epub 2024 Aug 21.
- Individual participant dataSharing planned: No
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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.
Rehab H Werida, Ass Prof. study director
Damanhour 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 Egypt.
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 5 inclusion and 12 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 Jul 2023. 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 Egypt. 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?
Angiopoietin (ANG-2) rs55633437. (time frame: 1 month). 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 NCT05291338, which also lists 3 linked publications.
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 Jul 2023.